| Date Initiated by Firm | July 14, 2021 |
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| Create Date | August 11, 2021 |
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| Recall Status1 |
Terminated 3 on May 13, 2024 |
| Recall Number | Z-2242-2021 |
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| Recall Event ID |
88311 |
| PMA Number | P040033 |
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| Product Classification |
Prosthesis, hip, semi-constrained, metal/metal, resurfacing - Product Code NXT
|
| Product | smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery. |
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| Code Information |
Lot/Batch Codes: 20LW15962, 20LW15963 |
Recalling Firm/
Manufacturer |
Smith & Nephew Orthopaedics Ltd. (Aurora)
Aurora, Spa Park
Harrison Way
Leamington Spa United Kingdom
|
| For Additional Information Contact |
7971646246 |
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Manufacturer Reason
for Recall | The nail head may become detached during surgery. |
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FDA Determined
Cause 2 | Component change control |
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| Action | The firm notified its consignee by letter on 07/14/2021. The letter explained the issue and the hazard and requested the return of the products. |
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| Quantity in Commerce | 47 units |
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| Distribution | Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ. |
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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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| PMA Database | PMAs with Product Code = NXT
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