Device product
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.
Z-1513-2021
Product summary
- Event
- Event 87727
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1513-2021
Official wording
Reason: failed rivet at the chafe tab of arm sling.
Code information: Lot Numbers: 2021-01-05, 2021-01-20
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Derived failure modes
-
Unknown
failed rivet at the chafe tab of arm sling.