Betta Link Knotless Long - Implant Kit · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2023-05-04	Z-2060-2023	Class II	Open, Classified	Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.	N/A	clearance family

Regulatory clearances

510(k)K210498Substantially equivalent (SESE) · 2021-03-24clearance family

Predicate lineage

K210498

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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