FDA recall Z-1511-2021

DJ Orthopedics de Mexico S.A. de C.V. · Class II · 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.

Reason for recall

failed rivet at the chafe tab of arm sling.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

Key facts

Status: Terminated
Initiation date: 2021-04-12
Report date: 2021-05-05
Termination date: 2024-03-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tijuana, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2021