Medical device recalls Moderate risk

Biomet, Inc. recalls HipLOC CHS Plate/Lag Screw Introducer

Recall date
February 16, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0885-2016
FDA classification
Class II
Brand / firm
Biomet, Inc.
Sold / distributed
US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.

Why it was recalled

A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

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

What was recalled

HipLOC CHS Plate/Lag Screw Introducer

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