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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2018-12-19Z-0790-2019Class IITerminatedThis recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.Distribution: US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy.632 unitsclearance family
Regulatory clearances
  • 510(k)K170119Substantially equivalent (SESE) · 2017-09-29clearance family

Predicate lineage

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
DateTypeOutcomeFacilityCitations
2017-08-25NAINo action indicatedXTANT Medical Holdings, Inc0
2017-08-25NAINo action indicatedXTANT Medical Holdings, Inc0
2013-07-12VAIVoluntary action indicatedXTANT Medical Holdings, Inc1
2013-07-12VAIVoluntary action indicatedXTANT Medical Holdings, Inc1
2013-07-11NAINo action indicatedXTANT Medical Holdings, Inc0
2013-07-11NAINo action indicatedXTANT Medical Holdings, Inc0
2013-01-28WLWarning LetterXTANT Medical Holdings, Inc—
2013-01-28WLWarning LetterXTANT Medical Holdings, Inc—
2013-01-28WLWarning LetterXTANT Medical Holdings, Inc—
2013-01-28WLWarning LetterXTANT Medical Holdings, Inc—
2012-07-27OAIOfficial action indicatedXTANT Medical Holdings, Inc6
2012-07-27OAIOfficial action indicatedXTANT Medical Holdings, Inc6
2012-07-26OAIOfficial action indicatedXTANT Medical Holdings, Inc12
2012-07-26OAIOfficial action indicatedXTANT Medical Holdings, Inc12
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