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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
2010-04-06Z-2214-2010TerminatedThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.—clearance family
2010-04-06Z-2215-2010TerminatedThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.—clearance family
2010-04-06Z-2216-2010TerminatedThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.—clearance family
2010-04-06Z-2217-2010TerminatedThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.—clearance family
Regulatory clearances

    Predicate lineage

    K061067

    Cited as predicate by: K102019, K241636, K251718

    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
    2017-09-01NAINo action indicatedZimmer Trabecular Metal Technology, Inc.0
    2015-05-11VAIVoluntary action indicatedZimmer Trabecular Metal Technology, Inc.3
    2013-06-06VAIVoluntary action indicatedZimmer Trabecular Metal Technology, Inc.1
    2012-05-21NAINo action indicatedZimmer Trabecular Metal Technology, Inc.0
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