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Wrist Drop w/ U-Cuff Hand Splint

PRIMO INC · Model WDS01LS · UDI-DI 00810006682489

ILH
10
510(k) clearances
48
Adverse events
1
Recalls
432
Facilities

Description

Wrist Drop w/ U-Cuff Hand Splint - Small (Left)

Recalls

DateFirmReason
2023-08-18North Coast Medical IncThe thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

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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.