Recall Z-1262-2009 ยท HTQ Broach
Zimmer Inc.
Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A reusable cutting instrument that is used in total knee arthroplasty surgery.
| Date | May 12, 2009 (initiated Mar 13, 2009) |
| Status | Terminated |
| Reason | The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions. |
| Root cause | Finished device change control |
| Action | Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities. Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131. |
| Quantity | 37 |
| Distribution | Worldwide Distribution -- US, Australia, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.