Tijuana, N/A, Mexico
DJ Orthopedics de Mexico S.A. de C.V. recalls
1 recall recorded since 2018, most recently on 12 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 April 2021
- Terminated
- 21 March 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1513-2021, Z-1514-2021, Z-1511-2021, Z-1512-2021
- 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.
- 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.
- 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.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.