Integra LifeSciences Recalls Ascension CMC Saddle Due to Labeling Discrepancies
Integra LifeSciences is recalling 467 Ascension CMC Saddle implants because the US Instruction for Use contains content discrepancies compared to the FDA-cleared version.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves labeling content discrepancies, which the rubric defines as typically low severity and unlikely to cause adverse health consequences.
Plain-English summary
Integra LifeSciences Corp. is recalling 467 units of the Ascension CMC Saddle, a medical device intended to resurface the proximal end of the first metacarpal in patients with various forms of arthritis or bone loss. The recall was initiated following a quality review that identified labeling content discrepancies between the Instruction for Use (IFU) distributed in the United States and the content cleared by the FDA.
The affected devices are distributed nationwide in the USA. The specific lot and serial numbers involved are 111602, 110864, 102815, 091515, 092563, and 110863, with product catalogue numbers CMC-410-10, CMC-410-20, CMC-410-30, and CMC-410-40.
Healthcare providers and patients should contact Integra LifeSciences Corp. for further information regarding the recall and appropriate next steps.
The recalled product
- 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…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 467
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot/Serial Number: 111602
- 110864
- 102815
- 091515
- 092563
- 110863. Product/Catalogue No: CMC-410-10
- CMC-410-20
- CMC-410-30
- CMC-410-40.
Distribution
Distributed nationwide across the United States.
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