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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
2018-06-22Z-2898-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2899-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2900-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2901-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2902-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2903-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2904-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2905-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2906-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
2018-06-22Z-2907-2018Class IITerminatedAfter a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.22,831 totalclearance family
Showing 1–10 of 18
Regulatory clearances
  • 510(k)K120352Substantially equivalent (SESE) · 2012-06-11clearance family

Predicate lineage

K120352

Cited as predicate by: K140309, K171152

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
2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2017-07-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2013-11-14NAINo action indicatedStryker Leibinger GmbH & Co. KG0
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