Device product
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.
Z-1512-2021
Product summary
- Event
- Event 87727
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1512-2021
Official wording
Reason: failed rivet at the chafe tab of arm sling.
Code information: Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18
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.