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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63613

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

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Event summary

Timeline bucket
October 04, 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

Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered

Z-0415-2013
Recall number
Z-0415-2013
Initiated
October 04, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
16 (5 USA)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)

Code information

Part 11-106054 Lot 528310

Distribution pattern

Nationwide Distribution including CA, IN, NC, OH, and UT.