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Recall Observatory FDA recall evidence

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

April 12, 2021

Class II

Product summary

Firm
DJ Orthopedics de Mexico S.A. de C.V.
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

    reason.no_named_rule · v1.0.0

    failed rivet at the chafe tab of arm sling.