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
Filler, bone void, calcium compound - Product Code MQV
Causa
Surgical tissue network inc., dba tissuenet inc. recalled their ultrafill dbm putty-porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316l stainless steel particulates.
Acción
Surgical Tissue Network sent a Notification of Voluntary Tissue Recall dated March 22, 2012, to all affected customers. The firm issued an additional notification letter on August 30, 2012. The letter identified the product, the problem, and action to be taken by the customer. Consignees were asked to return all listed products that remain in inventory. If the product was further distributed, they were asked to forward the recall information to their customers.
Customers were instructed to contact TissueNet's Customer Service Department at 800-465-8800 x283 to coordinate return/replacement of the affected product. Customers with questions were instructed to call 800-465-8800 x230.
For questions regarding this recall call 407-380-2424.
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
Filler, bone void, calcium compound - Product Code MQV
Causa
Surgical tissue network inc., dba tissuenet inc. recalled their ultrafill dbm putty-porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316l stainless steel particulates.
Acción
Surgical Tissue Network sent a Notification of Voluntary Tissue Recall dated March 22, 2012, to all affected customers. The firm issued an additional notification letter on August 30, 2012. The letter identified the product, the problem, and action to be taken by the customer. Consignees were asked to return all listed products that remain in inventory. If the product was further distributed, they were asked to forward the recall information to their customers.
Customers were instructed to contact TissueNet's Customer Service Department at 800-465-8800 x283 to coordinate return/replacement of the affected product. Customers with questions were instructed to call 800-465-8800 x230.
For questions regarding this recall call 407-380-2424.
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.
Offset bushings associated with the lots identified were mismarked: the rotational reference numbers on the tibial offset bushing were marked counterclockwise instead of clockwise; the femoral offset bushing did not include rotational markings.
Acción
Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.
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.
Offset bushings associated with the lots identified were mismarked: the rotational reference numbers on the tibial offset bushing were marked counterclockwise instead of clockwise; the femoral offset bushing did not include rotational markings.
Acción
Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.
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.
An engineering analysis has determined the solution calcar stem has the potential to result in impingement with a variety of heads. this impingement may not allow the stem and head to lock as intended. the amount of possible impingement varies depending on the femoral head. worst case condition: calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. it is evident that a.
Acción
Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939.
For questions regarding this recall call 574-267-8143.
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 recall was initiated because alphatec spine confirmed that the ti standard polyaxial screw assembly was laser marked with the incorrect length of 45 mm.
Acción
Alphatec Spine distributors who received the TI Standard Polyaxial Screw Assembly were contacted by phone and by email on December 9, 2010. A phone script was used as a recall notification to contact their three distributors who received the recalled products. The recall notification informed the customers of the problem identified and the action to be taken. Customers were informed that they will receive replacements within 2-3 days. Customers with questions were instructed to call (800) 922-1356.
For questions regarding this recall call 760-431-9286.
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
Reamer - Product Code HTO
Causa
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
Acción
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580.
Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m
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
Reamer - Product Code HTO
Causa
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
Acción
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580.
Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Zimmer is initiating a lot specific recall because affected lots could include an extra small inner pin instead of the required regular inner pin in the coonrad/morrey elbow replacement set and the new ulnar revision kit .
Acción
Zimmer sent "URGENT MEDICAL DEVICE RECALL" letter dated November 19, 2012 to Distributors, Risk Managers/ Implanting Surgeons, and direct accounts. The notice describes the product, problem, risks and actions to be taken. Consignees were instructed to immediately locate, quarantine and return affected product with the completed Inventory Return Certification form to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 (US accounts) or Zimmer International Logistics GmbH, ATTN: Fao Tanja Herold (Recall Warsaw), Max-Immelmann-Allee 12 79427 Eschbach Germany for international accounts. If an implant is removed from customer inventory, they were directed to provide a copy of the Risk Manager letter upon retrieval of that implant(s) to ensure all facilities are aware of the removal. Surgeons are asked to consider risk information in the letter should a patient present with unexplained symtoms. Hospitals that received direct shipments from the Warsaw Distribution Center will be sent a copy of the Risk Manager letter directly. Questions and concerns along with information on any implanted product is to be addressed to CorporateQuality.PostMarket@zimmer.com using the provided spreadsheet or contact Zimmer at 1-800-447-5633.
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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
Zimmer spine has received reports of the peek ardis interbody spacer breaking into fragments when too much lateral force is applied to the ardis inserter. if the peek ardis interbody spacer breaks during implantation, surgical delays of up to 60 minutes could occur. sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. observed health risks.
Acción
Zimmer Spine, sent a "MEDICAL DEVICE CORRECTION" memo dated November 12, 2012 to all consignees / customers describing product, problem and actions to be taken including revised surgical technique. Beginning the week of December 17, 2012, Zimmer began the immediate retrieval of the affected units as a Class I recall. December 20, 2012 nation wide press outlining the recall was issued. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between the hours of 8AM and 5PM CST or by email at qualitycompliance@zimmer.com.
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.
Zimmer is initiating a lot specific recall because affected lots could include an extra small inner pin instead of the required regular inner pin in the coonrad/morrey elbow replacement set and the new ulnar revision kit .
Acción
Zimmer sent "URGENT MEDICAL DEVICE RECALL" letter dated November 19, 2012 to Distributors, Risk Managers/ Implanting Surgeons, and direct accounts. The notice describes the product, problem, risks and actions to be taken. Consignees were instructed to immediately locate, quarantine and return affected product with the completed Inventory Return Certification form to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 (US accounts) or Zimmer International Logistics GmbH, ATTN: Fao Tanja Herold (Recall Warsaw), Max-Immelmann-Allee 12 79427 Eschbach Germany for international accounts. If an implant is removed from customer inventory, they were directed to provide a copy of the Risk Manager letter upon retrieval of that implant(s) to ensure all facilities are aware of the removal. Surgeons are asked to consider risk information in the letter should a patient present with unexplained symtoms. Hospitals that received direct shipments from the Warsaw Distribution Center will be sent a copy of the Risk Manager letter directly. Questions and concerns along with information on any implanted product is to be addressed to CorporateQuality.PostMarket@zimmer.com using the provided spreadsheet or contact Zimmer at 1-800-447-5633.
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 items in this lot are missing the ion implantation feature. the surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. increased wear could potentially lead to a shorter implant life.
Acción
Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
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.
It was reported that the surgeon noticed that the echo 11mm hip stem had an etching indicating it was 13mm stem.
Acción
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions:
¿ Immediately locate and remove the identified device(s) listed below from circulation.
¿ Carefully follow the instructions on the enclosed FAX Back Response Form .
¿ Fax a copy of the Response Form to 574-372-1683 prior to return of product.
¿ Use priority carrier for your shipment.
Questions related to notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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.
An engineering analysis has determined the solution calcar stem has the potential to result in impingement with a variety of heads. this impingement may not allow the stem and head to lock as intended. the amount of possible impingement varies depending on the femoral head. worst case condition: calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. it is evident that a.
Acción
Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939.
For questions regarding this recall call 574-267-8143.
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.
An engineering analysis has determined the solution calcar stem has the potential to result in impingement with a variety of heads. this impingement may not allow the stem and head to lock as intended. the amount of possible impingement varies depending on the femoral head. worst case condition: calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. it is evident that a.
Acción
Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939.
For questions regarding this recall call 574-267-8143.
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.
An engineering analysis has determined the solution calcar stem has the potential to result in impingement with a variety of heads. this impingement may not allow the stem and head to lock as intended. the amount of possible impingement varies depending on the femoral head. worst case condition: calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. it is evident that a.
Acción
Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939.
For questions regarding this recall call 574-267-8143.