FDA-Device2026-09-23Class IIMISBRANDING
Reign Medical Clench Staple System (Compression) recalled — performance characteristics not established
What this means
Reign Medical's Clench Staple System (Compression) was distributed without adequate performance testing and requires additional FDA clearance. The device is used in bone fixation procedures. About 600 units were distributed nationwide.
- If you have this device in inventory, quarantine it and do not use it.
- Contact your distributor or Reign Medical for return instructions.
- If you have already implanted this device, consult your surgeon about next steps.
The agency's original wording
Hazard
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
Affected count
600
Manufactured in
6303 E 102nd St, N/A, Tulsa, OK, United States
Products
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 18mm/152-41818; 20mm x 20mm/152-42020
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3211-2026Want us to check the next one for you?
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