CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report

Screw Instrument Tray- Surgical Tray Product recalled by Biomet

Biomet is recalling Biomet Screw Instrument Tray- Surgical Tray Product, distributed nationwide in the US. The recall was initiated on 1 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled705 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-2363-2020
FDA event ID: 85641
Recalling firm: Biomet, Miami, FL
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2020
FDA classified: 12 Jun 2020
Reported: 24 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

1 May 2020	Recall initiated by company
12 Jun 2020	Classified by FDA	+42 days
24 Jun 2020	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

Device and tray that houses the device did not pass steam sterilization process validation testing

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003

Where it was distributed

Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND

Nationwide

Questions about this recall

Is Screw Instrument Tray- Surgical Tray Product recalled?

Yes. Biomet recalled Screw Instrument Tray- Surgical Tray Product on 1 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2363-2020.

Why was it recalled?

Device and tray that houses the device did not pass steam sterilization process validation testing

Which lots are affected?

All lots

Where was it sold?

Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND

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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