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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63711

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

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Event summary

Timeline bucket
November 06, 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

Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.

Z-0442-2013
Recall number
Z-0442-2013
Initiated
November 06, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

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Inspect official wording and provenance

Reason for recall

It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

Code information

Catalog Number: 192411 and Lot Number Identification: 244800

Distribution pattern

Nationwide distribution: USA including states of: AZ, MD, and KS.