DJ Orthopedics de Mexico S.A. de C.V. recalls DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical p…
- Recall date
- April 12, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1511-2021
- FDA classification
- Class II
- Brand / firm
- DJ Orthopedics de Mexico S.A. de C.V.
- Sold / distributed
- Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Why it was recalled
failed rivet at the chafe tab of arm sling.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
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