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Recall Observatory FDA recall evidence

Device product

TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S

Z-1247-2023

February 01, 2023

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 91702
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1247-2023

Official wording

Reason: TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

Code information: UDI-DI: 10886982097026 Lot Number: 611P035

Distribution pattern: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length