Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
- Company
- Biomet, Inc.
- Recall Initiated
- March 13, 2024
- Posted
- April 22, 2024
- Recall Number
- Z-1607-2024
- Quantity
- 19 units (1 US, 18 OUS)
- Firm Location
- Warsaw, IN
Reason for Recall
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Distribution
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Lot / Code Info
Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
Root Cause
Process change control
Action Taken
On March 27, 2024 URGENT MEDICAL DEVICE RECALL letters were via Email to Distributors and mail to customers. Customers were instructed to: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. This medical device recall was reported to the U.S. Food and Drug Administration and will be reported to other Competent Authorities, Notified Bodies, and Regulatory Authorities as required. Med Watch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s Med Watch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178. Under 21 CFR 803, manufacturers are also required to report any