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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63089

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

Open FDA event record

Event summary

Timeline bucket
August 22, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew 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

12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.

Z-2427-2012
Recall number
Z-2427-2012
Initiated
August 22, 2012
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
70 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

Code information

Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.

Field note

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