Reported Feb 22, 2017 · Terminated

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

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Lot codes and dates
  • 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw
Amount recalled
11

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 26, 2018 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.