Home / Recalls / DJ Orthopedics de Mexico S.A. de C.V. / Z-1513-2021

Z-1513-2021 Class II Terminated

Recalled by DJ Orthopedics de Mexico S.A. de C.V. — Tijuana, N/A

FDA device recall Z-1513-2021 was initiated by DJ Orthopedics de Mexico S.A. de C.V. on April 12, 2021 and is designated Class II. Reason for recall: failed rivet at the chafe tab of arm sling. The recall status is terminated (terminated March 21, 2024). Affected quantity: N/A.

Recall Details

Product Type: Devices
Report Date: May 5, 2021
Initiation Date: April 12, 2021
Termination Date: March 21, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - 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 Pattern

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

Code Information

Lot Numbers: 2021-01-05, 2021-01-20