FDAClass IIJuly 22, 2015

A.L.P.S recall

A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw

Why was A.L.P.S recalled?

Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.

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?

Part number:856135060 Lot: 061300

Product
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Recalling firm
Biomet, Inc.
Quantity
50 units
Distribution
Domestic: None. International: Netherlands and Japan
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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