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Recall Observatory FDA recall evidence

Device product

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

Z-2443-2023

July 24, 2023

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 92767
Status
Ongoing
Classification
Class II
Quantity
30 units
Official record key
device-enforcement:Z-2443-2023

Official wording

Reason: 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.

Code information: UDI/DI 03596010500922, Batch Number 21KSM0598

Distribution pattern: US, AE, CA, DE, ES, GB, MX, PA, PL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.