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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

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-11-09VAIVoluntary action indicatedBiomet, Inc.0
2023-11-09VAIVoluntary action indicatedBiomet, Inc.0
2020-01-30VAIVoluntary action indicatedBiomet, Inc.8
2020-01-30VAIVoluntary action indicatedBiomet, Inc.8
2018-08-24WLWarning LetterBiomet, Inc.—
2018-08-24WLWarning LetterBiomet, Inc.—
2018-04-24OAIOfficial action indicatedBiomet, Inc.11
2018-04-24OAIOfficial action indicatedBiomet, Inc.11
2017-08-17NAINo action indicatedZhejiang Biomet Medical Products Co. Ltd.0
2017-08-03VAIVoluntary action indicatedBiomet UK Ltd.4
2017-02-10NAINo action indicatedBiomet0
2017-02-03NAINo action indicatedBiomet France SARL0
2016-11-22OAIOfficial action indicatedBiomet, Inc.14
2016-11-22OAIOfficial action indicatedBiomet, Inc.14
2016-03-24NAINo action indicatedCHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.0
2015-06-03WLWarning LetterZhejiang Biomet Medical Products Co. Ltd.—
2015-03-18VAIVoluntary action indicatedBiomet UK Ltd.2
2015-01-22OAIOfficial action indicatedZhejiang Biomet Medical Products Co. Ltd.0
2014-06-30VAIVoluntary action indicatedBiomet, Inc.2
2014-06-30VAIVoluntary action indicatedBiomet, Inc.2
2013-01-18NAINo action indicatedBiomet0
2010-07-27WLWarning LetterBiomet, Inc.—
2010-07-27WLWarning LetterBiomet, Inc.—
2010-03-26NAINo action indicatedBiomet, Inc.0
2010-03-26NAINo action indicatedBiomet, Inc.0
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