FDA Device recall Z-1568-2013
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthri…
- FDA Device
- Class III
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class III recall of CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthri… by Integra Lifesciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1568-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-06-03 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1568-2013%22
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