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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
2025-08-15Z-2561-2025Class IIOpen, ClassifiedReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.61,334 UNITSclearance family
2024-03-06Z-1418-2024Class 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, Thailand66646 unitsclearance family
2024-03-06Z-1419-2024Class 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, Thailand7213 unitsclearance family
2024-03-06Z-1422-2024Class 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, Thailand24303 unitsclearance family
2024-03-06Z-1424-2024Class 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, Thailand1970 unitsclearance family
2024-03-06Z-1425-2024Class 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, Thailand591 unitsclearance family
2024-03-06Z-1423-2024Class 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, Thailand3648 unitsclearance family
2020-08-24Z-3019-2020Class IITerminatedExactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.Distribution: Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.125 devicesclearance family
2020-08-24Z-3020-2020Class IITerminatedExactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.Distribution: Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.149 devicesclearance family
Regulatory clearances

    Predicate lineage

    K082702

    Cited as predicate by: K191561, K213546, K223833

    K102951

    Cited as predicate by: K180632

    Cited as predicate by: K152267, K173388, K192097

    Cited as predicate by: K202024, K213546

    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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