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.
The firm received reports of a femoral head popping out of the liner intraoperatively.
Acción
Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken.
1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution.
2) Identify customers that received these products and immediately notify them of the recall.
3) Carry out a physical count and record the data on the Verification Section included in the letter.
4) Contact their inventory specialist for an RA# and record this on the Verification Section.
5) Return the Verfication Section even if they do not have the recalled product.
6) Return the recalled product to:
Smith & Nephew, Inc.
Attn: Return Goods
3303 Holmes Road
Memphis, TN 38118
Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010.
For any questions regarding this recall customers were to call (901) 399-5441.
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.
The firm received reports of a femoral head popping out of the liner intraoperatively.
Acción
Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken.
1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution.
2) Identify customers that received these products and immediately notify them of the recall.
3) Carry out a physical count and record the data on the Verification Section included in the letter.
4) Contact their inventory specialist for an RA# and record this on the Verification Section.
5) Return the Verfication Section even if they do not have the recalled product.
6) Return the recalled product to:
Smith & Nephew, Inc.
Attn: Return Goods
3303 Holmes Road
Memphis, TN 38118
Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010.
For any questions regarding this recall customers were to call (901) 399-5441.
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.
The firm received reports of a femoral head popping out of the liner intraoperatively.
Acción
Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken.
1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution.
2) Identify customers that received these products and immediately notify them of the recall.
3) Carry out a physical count and record the data on the Verification Section included in the letter.
4) Contact their inventory specialist for an RA# and record this on the Verification Section.
5) Return the Verfication Section even if they do not have the recalled product.
6) Return the recalled product to:
Smith & Nephew, Inc.
Attn: Return Goods
3303 Holmes Road
Memphis, TN 38118
Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010.
For any questions regarding this recall customers were to call (901) 399-5441.
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.
Stryker orthopaedics has become aware that there is a potential for the shoulder screw on the scorpio sizing guide (the "sizing guide") to disassociate from the main body of the instrument.
Acción
Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.
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.
Stryker orthopaedics has become aware that there is a potential for the shoulder screw on the scorpio sizing guide (the "sizing guide") to disassociate from the main body of the instrument.
Acción
Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.
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.
Notas adicionales en la data
Ligament Fixation Device - Product Code MBI
Causa
During surgical procedure the product has the potential for separation of the plug guide.
separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
Acción
On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.
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.
Notas adicionales en la data
Burr, orthopedic - Product Code HTT
Causa
Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
Acción
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.
2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.
3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661.
If they have distributed any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
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.
Notas adicionales en la data
Burr, orthopedic - Product Code HTT
Causa
Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
Acción
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.
2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.
3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661.
If they have distributed any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
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.
Notas adicionales en la data
Burr, orthopedic - Product Code HTT
Causa
Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
Acción
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.
2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.
3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661.
If they have distributed any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
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.
Notas adicionales en la data
Burr, orthopedic - Product Code HTT
Causa
Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
Acción
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.
2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.
3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661.
If they have distributed any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
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.
Notas adicionales en la data
Burr, orthopedic - Product Code HTT
Causa
Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
Acción
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.
2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.
3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661.
If they have distributed any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
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.
Notas adicionales en la data
Burr, orthopedic - Product Code HTT
Causa
Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
Acción
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.
2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.
3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661.
If they have distributed any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
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.
Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
Acción
Orthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322.
Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.
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.
When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. the stem may have to be removed from the patient in order to disengage the inserter from the stem. if the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter.
Acción
The firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756.
Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.
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.
When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. the stem may have to be removed from the patient in order to disengage the inserter from the stem. if the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter.
Acción
The firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756.
Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.
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.
The device has the potential to not appropriately mate with the humeral stem.
Acción
DJO Surgical sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers.
The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA.
Questions are directed to the Director of Commercial Logistics at 512-834-6330.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
Notas adicionales en la data
Hip Prosthesis, Porous Coated Femoral Stem - Product Code MBL
Causa
Tests on pvc packaging material resulted in alert levels for cytotoxicity.
Acción
Ortho Development Corporation notified consignees by letter on May 11, 2011. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to return all remaining affected units to Ortho. Replacement product was to be shipped by May 31.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
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.
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
Acción
The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.
Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.