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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65362

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corp.

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

CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

Z-1568-2013
Recall number
Z-1568-2013
Initiated
June 03, 2013
Classification
Class III
Status
Terminated
Quantity
467 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.

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

As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.

Code information

Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40.

Distribution pattern

USA Nationwide Distribution