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VFT

LDR Spine Usa, Inc. · Model VF2326P · UDI-DI 03662663025409

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

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.