Recall Z-1220-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1220-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-01-10, terminated 2018-03-26. It names one FDA 510(k) clearance: K121589. Product: 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw. Reason: The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Terminated: 2018-03-26
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K121589 — BIOMET MICROFIXATION FACIAL PLATING SYSTEMBiomet Microfixation·cleared 2012-09-21

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

1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw

Reason for recall

The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

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