F & A Foundation Reign Medical Clench Staple System (Compression), Description/REF: 9mm x recall — FDA Z-3211-2026
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Overview of recall records associated with F & A Foundation, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
This page summarizes recall records in which the official source identifies F & A Foundation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.