Recall Z-1241-2024— Synthes (USA) Products LLC

Name: FDA recall Z-1241-2024
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: K201321. Product: VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S. 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

K201321 — DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemDePuy Synthes·cleared 2020-07-24

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

VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S

Reason for recall

Products not sterilized, sterility cannot be confirmed

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