| Date Initiated by Firm | August 31, 2006 |
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| Date Posted | November 21, 2006 |
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| Recall Status1 |
Terminated 3 on May 03, 2012 |
| Recall Number | Z-0196-2007 |
|---|
| Recall Event ID |
36311 |
| 510(K)Number | K010434 |
|---|
| Product Classification |
Tibial Tray - Product Code JWH
|
| Product | Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02 |
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| Code Information |
Serial numbers 0886395-0886424 |
Recalling Firm/
Manufacturer |
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
|
Manufacturer Reason
for Recall | Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine. |
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| Quantity in Commerce | 30 |
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| Distribution | International distribution only---- including countries of South America, Africa and Europe |
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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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