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U.S. Department of Health and Human Services

Class 2 Device Recall DRAD SelfTapping Locking Screw

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  Class 2 Device Recall DRAD SelfTapping Locking Screw see related information
Date Initiated by Firm March 07, 2018
Date Posted March 20, 2018
Recall Status1 Terminated 3 on October 31, 2018
Recall Number Z-1317-2018
Recall Event ID 79515
510(K)Number K132296  
Product Classification Screw, fixation, bone - Product Code HWC
Product D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
Code Information Lot Number 17GM04522
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.
Quantity in Commerce 59 units
Distribution US, Puerto Rico, Malaysia
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 = HWC and Original Applicant = SMITH & NEPHEW, INC.
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