Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1220-2017 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2017-01-10
Date Terminated2018-03-26
Product Quantity11

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.

Firm Action

Zimmer Biomet initiated a voluntary recall of 1.5mm System due to identification of non-conformance with off-centered slots and the no-go gage starting in the pilot hole. One distributor with affected product outside of Zimmer Biomet control was notified via email and asked to return the affected product. This communication was sent on via e-mail on January 10, 2017. All product has been returned.There were 89 units in Zimmer Biomet control at the time the removal was initiated, however all 100 are now in Zimmer Biomet control. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Phone: 800-348-2759

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic: None VA/DOD: None Foreign: Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121589BIOMET MICROFIXATION FACIAL PLATING SYSTEMBiomet Microfixation · 2012-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑