CMC Saddle Product Usage: The Ascension CMC is intended recall: Labeling Error
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis…
Why was CMC Saddle Product Usage: The Ascension CMC is intended recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: 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…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 467 devices
- Distribution
- USA Nationwide Distribution
- Recall date
- July 3, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)