CMC Saddle Product Usage: The Ascension CMC is intended to resurface… — Class III medical device recall Z-1568-2013
Terminated recall by Integra LifeSciences Corp., reported 2013-07-03, distributed nationwide. As a result of a quality review, labelling content discrepancies were identified between the Instruction for U
| Recall number | Z-1568-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2013-06-03 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 467 devices |
| Serial numbers | 091515, 092563, 102815, 110863, 110864, 111602, CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40 |
| Model numbers | CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1568-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.