Data Foundry

Medical device recalls 2023

TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE — Class II medical device recall Z-1248-2023

Ongoing recall by Synthes (USA) Products LLC, reported 2023-03-22, distributed nationwide. TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and

Recall numberZ-1248-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSynthes (USA) Products LLC, West Chester, PA, United States
Recall initiated2023-02-01
Classified2023-03-10
Reported by FDA2023-03-22
DistributedNationwide (US)
Countries outside the USCA, JP
Quantity6 units
Reason classeslabeling
UPC / GTIN / UDI-DI10886982097262
Lot numbers610P788
Model numbers04.037.242S

Product

TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1248-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.