Recall Z-1513-2021— DJ Orthopedics de Mexico S.A. de C.V.
Class II · Terminated
Class II FDA medical device recall by DJ Orthopedics de Mexico S.A. de C.V., initiated 2021-04-12, terminated 2024-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: failed rivet at the chafe tab of arm sling..
- Recalling firm
- DJ Orthopedics de Mexico S.A. de C.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-12
- Terminated
- 2024-03-21
- Firm location
- Tijuana, N/A, Mexico
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.