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MODULIFT

Aesculap AG · Model MF622T · UDI-DI 04046964501159

MQP Prescription
10
510(k) clearances
2,930
Adverse events (14 deaths)
46
Recalls
223
Facilities

Description

MODULIFT VBR SZ.S 12X14MM 19-23MM 5°

Recalls

DateFirmReason
2022-11-10NuVasive IncPotential that insert will be unable to disengage from the vertebral body replacement device/implant
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.