# FDA recall Z-3211-2026

> **F & A Foundation** · Class II · device recall initiated 2026-07-15.

## 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

## 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.

## Key facts

- **Recall number:** Z-3211-2026
- **Recalling firm:** F & A Foundation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-15
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tulsa, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3211-2026

## Citation

> MORVS. FDA recall Z-3211-2026. Retrieved 2026-10-25 from https://api.morvs.ai/recall/Z-3211-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*