CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report

TraumaOne System Surgical Tray recalled by Biomet Microfixation

Biomet Microfixation is recalling Biomet Microfixation TraumaOne System Surgical Tray, distributed in Alabama, Missouri, Utah. The recall was initiated on 11 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720

Quantity recalled33 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-2073-2017
FDA event ID: 77022
Recalling firm: Biomet Microfixation, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 11 Apr 2017
FDA classified: 12 May 2017
Reported: 24 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

11 Apr 2017	Recall initiated by company
12 May 2017	Classified by FDA	+31 days
24 May 2017	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

Part of the number on the tray lid differ from the part number on the base.

Product as listed by the FDA

Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

Where it was distributed

AL, MO and UT Canada, Australia, Netherlands, and Egypt

Alabama Missouri Utah

Questions about this recall

Is TraumaOne System Surgical Tray recalled?

Yes. Biomet Microfixation recalled TraumaOne System Surgical Tray on 11 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2073-2017.

Why was it recalled?

Part of the number on the tray lid differ from the part number on the base.

Which lots are affected?

Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720

Where was it sold?

AL, MO and UT Canada, Australia, Netherlands, and Egypt

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.

More recalls from Biomet Microfixation

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Reported	Class	Recall	Company	Reason	Where
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28 Oct 2015Device	CLASS II	Neuro Combo Set Case The cases hold surgical recalled	Biomet Microfixation	Other	Nationwide
17 Dec 2014Device	CLASS II	Total Temporomandibular Joint Replacement System- Lft Stand recalled	Biomet Microfixation	Other	Nationwide
17 Dec 2014Device	CLASS II	Total Temporomandibular Joint Replacement System- Lft Stand recalled	Biomet Microfixation	Other	Nationwide

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