FDAClass IIMarch 2, 2016

HipLOC CHS Plate/Lag Screw Introducer recall

HipLOC CHS Plate/Lag Screw Introducer

Why was HipLOC CHS Plate/Lag Screw Introducer 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.

Product
HipLOC CHS Plate/Lag Screw Introducer
Recalling firm
Biomet, Inc.
Quantity
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.
Recall date
March 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls