Reign Medical Clench Staple System Recalled for Unestablished Performance
F & A Foundation is recalling 600 units of Reign Medical Clench Staple Systems because the device's performance characteristics have not been adequately established.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical, stemming from unestablished performance characteristics rather than a confirmed defect causing harm.
Plain-English summary
F & A Foundation is recalling 600 units of the Reign Medical Clench Staple System (Compression). The affected products are distributed in Texas, Oklahoma, Maryland, Vermont, Massachusetts, and Louisiana. The recall covers various sizes and reference numbers, including 9mm x 7mm, 11mm x 10mm, 15mm x 12mm, 18mm x 18mm, and 20mm x 20mm configurations.
The recall was initiated because the bone fixation staple requires a new 510(k) clearance. The performance characteristics of this device have not been adequately established, meaning the device may not function as intended for its intended use.
Healthcare providers and facilities that have received these devices should stop using them and contact F & A Foundation for instructions on return or replacement. Consumers who have purchased these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x…
- Manufacturer
- F & A Foundation
- Affected units
- 600
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 (10)
- REF/UDI-DI/Lot/Expiration: 152-30907/00854325007011/24-0627/10/27/2029
- 152-31110/00854325007028/24-0628/10/21/2029
- 152-31512/00854325007042/24-0629/10/22/2029
- 152-31818/00854325007073/24-0630/10/23/2029
- 152-32020/00854325007189/24-0631/10/28/2029
- 152-40907/00854325007010/24-0633/10/16/2029
- 152-41110/00854325007127/24-0634/10/20/2029
- 152-41512/00854325007141/24-0635/10/20/2029
- 152-41818/00854325007172/24-0636/10/16/2029
- 152-42020/00854325007189/24-0637/10/16/2029
Distribution
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