Recall Z-1240-2024— Synthes (USA) Products LLC
Class II · Ongoing
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2024-01-24. It names 2 FDA 510(k) clearances: K160167, K131548. Product: TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S. Reason: Products not sterilized, sterility cannot be confirmed.
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-24
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K160167 — DePuy Synthes TFNA Augmentation System
- K131548 — SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
Reason for recall
Products not sterilized, sterility cannot be confirmed
Data sourced from openFDA. This site is unofficial and independent of the FDA.