CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

Gentle Threads Interference Screw 10x25mm Round Head recalled by Biomet

Biomet is recalling Gentle Threads Interference Screw 10x25mm Round Head, distributed nationwide in the US. The recall was initiated on 3 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 905620 Lot: 824610

Quantity recalled53 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-1944-2015
FDA event ID: 71526
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2015
FDA classified: 30 Jun 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

3 Jun 2015	Recall initiated by company
30 Jun 2015	Classified by FDA	+27 days
8 Jul 2015	Published in enforcement report	+8 days

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

Reason for recall

Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

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

Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.

Where it was distributed

Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.

Nationwide

Questions about this recall

Is Gentle Threads Interference Screw 10x25mm Round Head recalled?

Yes. Biomet recalled Gentle Threads Interference Screw 10x25mm Round Head on 3 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-1944-2015.

Why was it recalled?

Which lots are affected?

Part Number: 905620 Lot: 824610

Where was it sold?

Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.

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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