DJ Orthopedics de Mexico S.A. de C.V.: Medical Device Recall in 2021 - (Recall #: Z-1512-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Product Classification:

Class II

Date Initiated: April 12, 2021

Date Posted: May 5, 2021

Recall Number: Z-1512-2021

Event ID: 87727

Reason for Recall:

failed rivet at the chafe tab of arm sling.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated