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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66967

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

Open FDA event record

Event summary

Timeline bucket
November 26, 2013
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

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

Z-0493-2014
Recall number
Z-0493-2014
Initiated
November 26, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
532 in USA all under Biomet USA control

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label, and patient label all have the incorrect

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

Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.

Code information

Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736

Distribution pattern

Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.