Z-3211-2026Class II

Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x...

Name: Z-3211-2026 Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x...
Creator: F & A Foundation
Published: 2026-07-15
License: https://open.fda.gov/license/

F & A Foundation / initiated 2026-07-15 / Open, Classified

FDA source

Recall record

Recall number: Z-3211-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-15
Posted: 2026-09-17
Recalling firm: F & A Foundation
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 18mm/152-41818; 20mm x 20mm/152-42020
Product code: JDR Staple, Fixation, Bone
Reason for recall: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
FDA root cause: No Marketing Application
Action: 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]
Quantity in commerce: 600
Distribution: US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3211-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3211-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-17

Product code JDR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)