Reported May 5, 2021 · Terminated

DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical…

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DJ Orthopedics de Mexico S.A. de C.V. · Carretera Libre Tijuana-Tecate · Tijuana, N/A · N/A

DONJOY REF11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY
UDI(01)00190446673552 -
Product Usageintended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck

Lot codes and dates: 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
Amount recalled: N/A

The agency filed one notice per product. You are reading one of them; the other 3 are below.

failed rivet at the chafe tab of arm sling.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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