Radar · device · signal

Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mmRecall or enforcement action

Complete coverage checks before an early-window claim.

Statistical status

No screen yet

Receipt-date counts have not been screened.

Evidence score

—

Research priority weight, not a probability of causation or recovery.

Missing: none recorded

Competition

unknown

Observed in monitored channels only. Unknown is not zero.

Coverage unknown. Early-window label is blocked.

What changed

Qualitative review · notice
Enforcement report. This is a product action, not an injury count. Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
10/09/2026 · A recall may not involve the injury later investigated.
Read the source

Receipt dates are the reporting screen. Event dates are a separate, lag-sensitive series. They are not added together.

Basis	Window	Covered days	Reports	Expected	Fold	Complete

Unknown. Court and RECAP collectors are not in this release. Do not read a blank docket as zero lawsuits.

No firm pages or ad notes. Competition stays unknown until the panel records one.