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Recall Observatory FDA recall evidence

Device product

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.

Z-1511-2021

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-1511-2021

Official wording

Reason: failed rivet at the chafe tab of arm sling.

Code information: Lot Numbers: 2020-11-17, 2020-11-28, 2020-11-29, 2020-11-30, 2020-12-02, 2020-12-07, 2020-12-09, 2020-12-10, 2020-12-11, 2020-12-12, 2020-12-13, 2021-01-12, 2021-01-13, 2021-01-14, 2021-01-15, 2021-01-20, 2021-02-02, 2021-02-03, 2021-02-04, 2021-02-05, 2021-02-09, 2021-02-11, 2021-02-12, 2021-02-13, 2021-02-14, 2021-02-15, 2021-02-16, 2021-02-21, 2021-02-22, 2021-02-23, 2021-02-24, 2021-02-25, 2021-02-27, 2021-02-28, 2021-03-01, 2021-03-02, 2021-03-03, 2021-03-04, 2021-03-09, 2021-03-10, 2021-03-11, 2021-03-12, 2021-03-13, 2021-03-18, 2021-03-19

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.