PlainRecalls
FDA Devices Moderate Class II Terminated

HipLOC CHS Plate/Lag Screw Introducer

Reported: March 2, 2016 Initiated: February 16, 2016 #Z-0885-2016

Product Description

HipLOC CHS Plate/Lag Screw Introducer

Reason for Recall

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
23 units
Distribution
US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
HipLOC CHS Plate/Lag Screw Introducer. Recalled by Biomet, Inc.. Units affected: 23 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0885-2016.