Date Initiated by Firm | February 12, 2008 |
Date Posted | July 25, 2008 |
Recall Status1 |
Terminated 3 on December 22, 2009 |
Recall Number | Z-1375-2008 |
Recall Event ID |
46708 |
510(K)Number | K023546 |
Product Classification |
Knee Prosthesis - Product Code JWH
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Product | Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448. |
Code Information |
Lot 743430. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
|
For Additional Information Contact | Mary Hardesty 800-348-9500 |
Manufacturer Reason for Recall | Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure. |
FDA Determined Cause 2 | Packaging process control |
Action | Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians. |
Quantity in Commerce | 4 |
Distribution | Worldwide: USA and Australia |
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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