| Date Initiated by Firm | June 02, 2005 |
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| Date Posted | August 18, 2005 |
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| Recall Status1 |
Terminated 3 on October 24, 2008 |
| Recall Number | Z-1379-05 |
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| Recall Event ID |
32568 |
| 510(K)Number | K932776 |
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| Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
| Product | The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''. |
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| Code Information |
Serial number range 0696020 - 0696061. |
Recalling Firm/
Manufacturer |
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
|
Manufacturer Reason
for Recall | Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information. |
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FDA Determined
Cause 2 | Other |
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| Action | All consignees were notified by letter on 06/02/2005. |
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| Quantity in Commerce | 41 |
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| Distribution | Distributed to 15 Domestic Consignees 4 Foreign Distributors. |
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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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| 510(K) Database | 510(K)s with Product Code = JWH
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