Tulsa, OK, United States
F & A Foundation recalls
1 recall recorded since 2018, most recently on 15 July 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 July 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3211-2026
- 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 10m
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.