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Zuma-L™

Seaspine Orthopedics Corporation · Model 56-5616 · UDI-DI 10889981059637

MQP OVD Prescription

510(k) clearances

2,930

Adverse events (14 deaths)

Recalls

223

Facilities

Description

Zuma-L Implant, 55mm x 18mm x 16mm, 0 Deg

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.