FDAApril 12, 2021device
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
failed rivet at the chafe tab of arm sling.
What to do
FDA enforcement status: Terminated
Brands named
dj orthopedics de mexico s a de c v
UPCs
00190446683667
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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