CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

Hard Tissue Replacement (HTR) Implant recalled by Biomet Microfixation

Biomet Microfixation is recalling Hard Tissue Replacement (HTR) Implant, distributed in 8 states. The recall was initiated on 13 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCustom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016

Quantity recalled54 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-2751-2016
FDA event ID: 74798
Recalling firm: Biomet Microfixation, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 13 Jun 2016
FDA classified: 8 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

13 Jun 2016	Recall initiated by company
8 Sep 2016	Classified by FDA	+87 days
14 Sep 2016	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

Potential sterility deficiency.

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

Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.

Where it was distributed

Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.

Arizona California Florida Missouri New Hampshire Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

Potential sterility deficiency.

Which lots are affected?

Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016

Where was it sold?

Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.

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 26 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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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	CA, MN, PA
17 Dec 2014Device	CLASS II	Total Temporomandibular Joint Replacement System- Lft Stand recalled	Biomet Microfixation	Other	CA, MN, PA

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