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Class 2 Device Recall BHR SQUARE HEADED NAIL |
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Date Initiated by Firm |
July 14, 2021 |
Create Date |
August 11, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2242-2021 |
Recall Event ID |
88311 |
PMA Number |
P040033 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/metal, resurfacing - Product Code NXT
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Product |
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery. |
Code Information |
Lot/Batch Codes: 20LW15962, 20LW15963 |
Recalling Firm/ Manufacturer |
Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom
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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 |
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. |
Quantity in Commerce |
47 units |
Distribution |
Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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PMA Database |
PMAs with Product Code = NXT and Original Applicant = Smith & Nephew, Inc.
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