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Reign Medical Clench Staple System (Compression)… recallZ-3211-2026 · F & A Foundation · initiated Jul 15, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from F & A Foundation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: No Marketing Application

What the company is doing

On 7/15/2026, recall notices were mailed to customers who were asked to do the following: 1) Discontinue use of the affected product immediately. 2) Quarantine any remaining inventory of the recalled product. 3) Follow the attached customer action instructions for guidance on product return. 3) Share this notification with all device users within your facility and network to ensure they are aware of this recall. This notification should also be shared with any organization where the potentially affected devices, or care of patients with potentially affected devices implanted, have been transferred. 4) Follow any recommended patient management or alternative product guidance. Care providers should monitor patients for any adverse events and notify Reign Medical immediately of any such occurrence. 5) Complete and return the response form to [email protected]

Recall details

Recall number
Z-3211-2026
Status
Open, Classified
Initiated by the company
Jul 15, 2026
Posted by the FDA
Sep 17, 2026
Recalling firm
F & A Foundation
Quantity
600
Product code
JDR
Distribution
US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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