Recall Z-1234-2024— Synthes (USA) Products LLC

Name: FDA recall Z-1234-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-24

Class II · Ongoing

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2024-01-24. It names one FDA 510(k) clearance: K051678. Product: 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S. 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

1 on FDA's record

K051678 — SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEMSynthes (Usa)·cleared 2005-09-21

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

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S

Reason for recall

Products not sterilized, sterility cannot be confirmed

Data sourced from openFDA. This site is unofficial and independent of the FDA.