| | Class 2 Device Recall Zimmer NEXGEN Tibial Broach Impactor |  |
| Date Initiated by Firm | June 30, 2008 |
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| Date Posted | September 20, 2008 |
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| Recall Status1 |
Terminated 3 on November 12, 2009 |
| Recall Number | Z-2301-2008 |
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| Recall Event ID |
48717 |
| Product Classification |
Broach Impactor - Product Code HWA
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| Product | 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.. |
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| Code Information |
All units. |
Recalling Firm/
Manufacturer |
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
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| For Additional Information Contact |
574-372-4487 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| 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. |
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| Quantity in Commerce | 1439 |
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| Distribution | Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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