Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during
FDA device recall Z-2301-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWA
- Quantity affected
- 1439
- Distribution
- Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
- Date initiated
- 2008-06-30
- Date posted
- 2008-09-20
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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