Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1513-2021 — DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

U.S. FDA — Device Enforcement · Mexico · 2021-04-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1513-2021
Date of alert
2021-04-12
Country / jurisdiction
Mexico
Risk level
Class II
Risk type
recall
Brand
DJ Orthopedics de Mexico S.A. de C.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00190446683674
Reported risk: failed rivet at the chafe tab of arm sling.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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