Home / Recalls / DJ Orthopedics de Mexico S.A. de C.V. / Z-1514-2021

Z-1514-2021 Class II Terminated

Recalled by DJ Orthopedics de Mexico S.A. de C.V. — Tijuana, 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:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - 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, 2021-03-10, 2021-03-11, 2021-03-16

Other recalls by DJ Orthopedics de Mexico S.A. de C.V.

  • Z-1512-2021 Class II — DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 0019 (April 12, 2021)
  • Z-1513-2021 Class II — DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190 (April 12, 2021)
  • Z-1511-2021 Class II — DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 (April 12, 2021)