CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases o
FDA device recall Z-1568-2013 · posted 2013-06-21 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KYI
- Quantity affected
- 467 devices
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-06-03
- Date posted
- 2013-06-21
- Date terminated
- 2014-10-08
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (K061451) | Ascension Orthopedics, Inc. | 2006-08-11 |