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REEF L

Seaspine Orthopedics Corporation · Model RL2-003002 · UDI-DI 10889981322014

HTF Prescription
3
510(k) clearances
116
Adverse events (2 deaths)
2
Recalls
316
Facilities

Description

M/L Angled Domed Rake Curette

Recalls

DateFirmReason
2024-11-12MEDLINE INDUSTRIES, LP - NorthfieldWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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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.