Recall Z-1568-2013 ยท KYI Prosthesis, Wrist, Carpal Trapezium
Integra LifeSciences Corp.
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.
| Date | Jun 21, 2013 (initiated Jun 3, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | Integra sent an Urgent: Medical Device Recall letter to all affected product. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, discontinue use, and complete and return the attached form. When the form is received, Customer Service Returns and Repairs will send an RMA number to return the affected inventory. For quwstions contact your regional managers or call 512-520-7697. |
| Quantity | 467 devices |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 Ascension Orthopedics, Inc., Aug 11, 2006 |