FDA recall Z-1036-2023

Biomet, Inc. · Class II · device

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 for recall

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

Distribution

US Nationwide distribution in the states of CA, KY, FL.

Key facts

Status
Ongoing
Initiation date
2022-11-29
Report date
2023-02-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1036-2023