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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
2024-03-06Z-1420-2024Class IIOpen, ClassifiedThe packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand2806 unitsclearance family
2024-03-06Z-1421-2024Class IIOpen, ClassifiedThe packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand447 unitsclearance family
2023-11-21Z-0579-2024Class IIOpen, ClassifiedExactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.Distribution: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UKN/Aclearance family
Regulatory clearances
  • 510(k)K180632Substantially equivalent (SESE) · 2018-07-25clearance 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
2025-12-19WLWarning LetterExactech Sarasota, Inc.—
2025-08-27OAIOfficial action indicatedExactech, Inc.9
2025-08-27OAIOfficial action indicatedExactech, Inc.9
2025-07-25OAIOfficial action indicatedExactech Sarasota, Inc.7
2024-10-09VAIVoluntary action indicatedExactech, Inc.0
2024-10-09VAIVoluntary action indicatedExactech, Inc.0
2024-01-19WLWarning LetterExactech, Inc.—
2024-01-19WLWarning LetterExactech, Inc.—
2023-09-26OAIOfficial action indicatedExactech, Inc.2
2023-09-26OAIOfficial action indicatedExactech, Inc.2
2021-11-17VAIVoluntary action indicatedExactech, Inc.4
2021-11-17VAIVoluntary action indicatedExactech, Inc.4
2020-01-31VAIVoluntary action indicatedExactech, Inc.7
2020-01-31VAIVoluntary action indicatedExactech, Inc.7
2017-03-10VAIVoluntary action indicatedExactech, Inc.7
2017-03-10VAIVoluntary action indicatedExactech, Inc.7
2015-07-16NAINo action indicatedExactech, Inc.0
2015-07-16NAINo action indicatedExactech, Inc.0
2014-08-25NAINo action indicatedExactech Sarasota, Inc.0
2012-12-11NAINo action indicatedExactech, Inc.0
2012-12-11NAINo action indicatedExactech, Inc.0
2010-03-25VAIVoluntary action indicatedExactech, Inc.0
2010-03-25VAIVoluntary action indicatedExactech, Inc.0
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