Recall Z-2301-2008 ยท HWA Impactor
Zimmer Inc.
Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
| Date | Sep 20, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure. |
| Root cause | Device Design |
| Action | Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487. |
| Quantity | 1439 |
| Distribution | Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.