Recall Z-1036-2023— Biomet, Inc.

Name: FDA recall Z-1036-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-29

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2022-11-29. It names one FDA 510(k) clearance: K042409. Product: OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602. Reason: Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K042409 — MODULAR ARTHRODESIS NAILBiomet, Inc.·cleared 2004-12-02

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

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

Reason for recall

Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

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