Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic s…

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3155-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Why it was recalled

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.

Get recall alerts

Free email alert whenever Zimmer Biomet, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Zimmer Biomet, Inc.