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U.S. Department of Health and Human Services

Class 2 Device Recall smith&nephew TRIGEN

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  Class 2 Device Recall smith&nephew TRIGEN see related information
Date Initiated by Firm July 24, 2023
Date Posted August 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-2444-2023
Recall Event ID 92767
510(K)Number K040462  K210980  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Code Information UDI/DI 03596010500922, Batch Number 21KSM0606
Recalling Firm/
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
Manufacturer Reason
for Recall
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
FDA Determined
Cause 2
Process control
Action Smith & Nephew issued an Urgent Medical Device Recall Notice on 07/24/2023. The notice explained the problem with the product, the potential risk, and requested the consignees locate and quarantine the affected product for return. Sales reps, district offices, or distributors were directed to notify their customers and ensure that the required actions were complete. The firm is seeking return of the affected product.
Quantity in Commerce 32 units
Distribution US, AE, CA, DE, ES, GB, MX, PA, PL
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = SMITH & NEPHEW, INC.