DJ Orthopedics de Mexico S.A. de C.V.: Medical Device Recall in 2021 - (Recall #: Z-1511-2021)

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:11-0447-9-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.

Product Classification:

Class II

Date Initiated: April 12, 2021

Date Posted: May 5, 2021

Recall Number: Z-1511-2021

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: 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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated