FDA recall Z-3211-2026

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

Status

Ongoing

Initiation date

2026-07-15

Report date

2026-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tulsa, OK, United States

Primary source

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