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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
2025-04-03Z-1702-2025Class IIOpen, ClassifiedThe device was delivered with a preassembled Femoral Augment screw that was missing its thread.Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.1771 unitscode info di
Regulatory clearances

    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
    2026-02-19NAINo action indicatedWaldemar Link GmbH & Co. KG (Mfg Site)0
    2023-05-11VAIVoluntary action indicatedWaldemar Link GmbH & Co. KG (Mfg Site)5
    2015-01-22VAIVoluntary action indicatedWaldemar Link GmbH & Co. KG (Mfg Site)3
    2012-07-26NAINo action indicatedWaldemar Link GmbH & Co. KG (Mfg Site)0
    2010-09-16VAIVoluntary action indicatedWaldemar Link GmbH & Co. KG (Mfg Site)2
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