Recall Z-2965-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-2965-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-07-12, terminated 2020-05-01. It names one FDA 510(k) clearance: K081546. 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: A size 22mm threaded peg was found in the package of a 10mm unit..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Terminated: 2020-05-01
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K081546 — SMALL BONE LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc.·cleared 2008-08-26

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

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.

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