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Breckenridge® Intervertebral Body/VBR Fusion System

BIOMET SPINE LLC · Model 8814-1216 · UDI-DI 00887868211133

MQP MAX Prescription

510(k) clearances

2,930

Adverse events (14 deaths)

Recalls

223

Facilities

Recalls

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