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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63725

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

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Event summary

Timeline bucket
November 09, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, Inc.

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

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

Z-0527-2013
Recall number
Z-0527-2013
Initiated
November 09, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
49

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

Code information

Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)

Distribution pattern

Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.