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U.S. Department of Health and Human Services

Class 2 Device Recall Clench Compression Staple

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 Class 2 Device Recall Clench Compression Staplesee related information
Date Initiated by FirmJuly 15, 2026
Date PostedSeptember 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3211-2026
Recall Event ID 99515
Product Classification Staple, fixation, bone - Product Code JDR
ProductReign 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 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
FEI Number 3014527966
Recalling Firm/
Manufacturer		 F & A Foundation
6303 E 102nd St
Tulsa OK 74137-7041
Manufacturer Reason
for Recall		Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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 info@reignmedical.com
Quantity in Commerce600
DistributionUS Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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