F & A Foundation: 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; 9m

Is my product affected?

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

• UPC 00854325007011
• UPC 00854325007028
• UPC 00854325007042
• UPC 00854325007073
• UPC 00854325007189
• UPC 00854325007010
• UPC 00854325007127
• UPC 00854325007141
• UPC 00854325007172

Check against the official notice below — it lists the full affected range.

Hazard

Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

Details from the source

Reason for recall: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. Distribution: US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA. Quantity: 600 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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