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U.S. Department of Health and Human Services

Class 2 Device Recall BHR SQUARE HEADED NAIL

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  Class 2 Device Recall BHR SQUARE HEADED NAIL see related information
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
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
For Additional Information Contact
7971646246
Manufacturer Reason
for Recall		 The nail head may become detached during surgery.
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
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.
PMA Database PMAs with Product Code = NXT and Original Applicant = Smith & Nephew, Inc.
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