CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report

Sterile Trac System Thinflap Burr Hole Plate recalled by Biomet

Biomet is recalling Sterile Trac System Thinflap Burr Hole Plate, distributed nationwide in the US. The recall was initiated on 25 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 078390

Quantity recalled7428

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-0629-2021
FDA event ID: 86896
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2020
FDA classified: 17 Dec 2020
Reported: 23 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

25 Nov 2020	Recall initiated by company
17 Dec 2020	Classified by FDA	+22 days
23 Dec 2020	Published in enforcement report	+6 days

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

Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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

Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone

Where it was distributed

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Nationwide

Questions about this recall

Is Sterile Trac System Thinflap Burr Hole Plate recalled?

Yes. Biomet recalled Sterile Trac System Thinflap Burr Hole Plate on 25 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0629-2021.

Why was it recalled?

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Which lots are affected?

Lot 078390

Where was it sold?

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

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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