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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 TRIGENsee related information
Date Initiated by FirmJuly 24, 2023
Date PostedAugust 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2444-2023
Recall Event ID 92767
510(K)NumberK040462 K210980 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductTRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Code Information UDI/DI 03596010500922, Batch Number 21KSM0606
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactDavid Snyder
978-749-1440
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
ActionSmith & 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 Commerce32 units
DistributionUS, AE, CA, DE, ES, GB, MX, PA, PL
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
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