DJ Orthopedics de Mexico S.A. de C.V. Recall 87727
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.
DJ Orthopedics de Mexico S.A. de C.V. Recall 87727 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1513-2021 |
| Event ID | 87727 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom. |
| Recall Reason | failed rivet at the chafe tab of arm sling. |
| Device Classification | 20210505 |
| Device Code Info | Lot Numbers: 2021-01-05, 2021-01-20 |
| Center Classification Date | 20210429 |
| Recall Initiation Date | 20210412 |
| Recalling Firm | DJ Orthopedics de Mexico S.A. de C.V. |
| Initial Notification | |
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