FDAClass IIMay 25, 2016

Zimmer universal locking system recall

Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801

Why was Zimmer universal locking system recalled?

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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?

LOT: 63297474

Product
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
Recalling firm
Zimmer Manufacturing B.V.
Quantity
200
Distribution
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Recall date
May 25, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls