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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74798

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 13, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet Microfixation, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2751-2016
Recall number
Z-2751-2016
Initiated
June 13, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet Microfixation, LLC
Quantity
54 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential sterility deficiency.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential sterility deficiency.

Code information

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

Distribution pattern

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