CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

5 Cannulated Screw Tap - Bone fixation screw recalled by Biomet

Biomet is recalling Biomet 5 Cannulated Screw Tap - Bone fixation screw, distributed nationwide in the US. The recall was initiated on 14 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 624820 (01)00887868133732(17)260415(10)624820 867200 (01)00887868133732(17)260731(10)867200

Quantity recalled6 OUS

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-2303-2020
FDA event ID: 85701
Recalling firm: Biomet, Miami, FL
Classification: Class II
Status: Terminated
Recall initiated: 14 May 2020
FDA classified: 9 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

14 May 2020	Recall initiated by company
9 Jun 2020	Classified by FDA	+26 days
17 Jun 2020	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

Distributed to the field without having completed design history files or design transfer activities

Product as listed by the FDA

Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.

Nationwide Florida Georgia Missouri New York

Questions about this recall

Is 5 Cannulated Screw Tap - Bone fixation screw recalled?

Yes. Biomet recalled 5 Cannulated Screw Tap - Bone fixation screw on 14 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2303-2020.

Why was it recalled?

Distributed to the field without having completed design history files or design transfer activities

Which lots are affected?

Lot Number: 624820 (01)00887868133732(17)260415(10)624820 867200 (01)00887868133732(17)260731(10)867200

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.

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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