| Date Initiated by Firm | September 14, 2006 |
|---|
| Date Posted | October 21, 2006 |
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| Recall Status1 |
Terminated 3 on April 26, 2007 |
| Recall Number | Z-0057-2007 |
|---|
| Recall Event ID |
36348 |
| 510(K)Number | K961685 |
|---|
| Product Classification |
Patella - Product Code JWH
|
| Product | Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100. |
|---|
| Code Information |
Lot 2203528. |
Recalling Firm/
Manufacturer |
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
|
| For Additional Information Contact |
574-372-7333 |
|---|
Manufacturer Reason
for Recall | Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product. |
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| Quantity in Commerce | 9 |
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| Distribution | Nationwide. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = JWH
|
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