FDA recall Z-2965-2018

Zimmer Biomet, Inc. · Class II · device

Product

Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Reason for recall

A size 22mm threaded peg was found in the package of a 10mm unit.

Distribution

International Distribution to countries of: Japan and Netherlands.

Key facts

Status
Terminated
Initiation date
2018-07-12
Report date
2018-09-12
Termination date
2020-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2965-2018