PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 12, 2018 Initiated: July 12, 2018 #Z-2965-2018

Product Description

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
25 units
Distribution
International Distribution to countries of: Japan and Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 25 units.
Why was this product recalled?
A size 22mm threaded peg was found in the package of a 10mm unit.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2965-2018.