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Open, Classified

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail

FDA Recall Z-2444-2023 · Posted 2023-08-22

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2023-07-24
Product Quantity32 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US, AE, CA, DE, ES, GB, MX, PA, PL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 2022-11-14K040462TRIGEN TROCHANTERIC ANTEGRADE NAILSmith & Nephew, Inc. · 2004-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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