Date Initiated by Firm | December 12, 2007 |
Date Posted | January 31, 2008 |
Recall Status1 |
Terminated 3 on June 11, 2008 |
Recall Number | Z-0707-2008 |
Recall Event ID |
46141 |
510(K)Number | K915132 |
Product Classification |
Tibial Tray - Product Code JWH
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Product | Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581 |
Code Information |
Lot Number: 448740. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
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For Additional Information Contact | 800-348-9500 Ext. 1305 |
Manufacturer Reason for Recall | Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa. |
FDA Determined Cause 2 | Packaging process control |
Action | Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it. |
Quantity in Commerce | 8 |
Distribution | Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey. |
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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