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.
Reported: May 5, 2021 Initiated: April 12, 2021 #Z-1513-2021
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.
Details
- Recalling Firm
- DJ Orthopedics de Mexico S.A. de C.V.
- Units Affected
- N/A
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
- Location
- Tijuana, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DJ Orthopedics de Mexico S.A. de C.V.. Units affected: N/A.
Why was this product recalled? ▼
failed rivet at the chafe tab of arm sling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 5, 2021. Severity: Moderate. Recall number: Z-1513-2021.
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