U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding changes/updates made to instructions for use. 3rd Party Publications
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.