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ReLine

Nuvasive, Inc. · Model 13325550P · UDI-DI 00887517039217

PMLNKBKWP Prescription
1
510(k) clearances
317
Adverse events (8 deaths)
2
Recalls
81
Facilities

Description

RELINE-O Screw+LS, 5.5x50mm 2S Red

Recalls

DateFirmReason
2023-11-28Icotec Agicotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th
2023-11-28Icotec Agicotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th

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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.