CLASS II Device recall · Reported 22 Jul 2015 · FDA Enforcement Report

A.L.P.S. Cortical Locking Screw. Bone fixation screw recalled by Biomet

Biomet is recalling A.L.P.S. Cortical Locking Screw. Bone fixation screw, distributed nationwide in the US. The recall was initiated on 4 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number:856135060 Lot: 061300

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2058-2015
FDA event ID: 71423
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2015
FDA classified: 10 Jul 2015
Reported: 22 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

4 Jun 2015	Recall initiated by company
10 Jul 2015	Classified by FDA	+36 days
22 Jul 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

Domestic: None. International: Netherlands and Japan

Nationwide

Questions about this recall

Is A.L.P.S. Cortical Locking Screw. Bone fixation screw recalled?

Yes. Biomet recalled A.L.P.S. Cortical Locking Screw. Bone fixation screw on 4 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2058-2015.

Why was it recalled?

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

Which lots are affected?

Part number:856135060 Lot: 061300

Where was it sold?

Domestic: None. International: Netherlands and Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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