Recall Z-1512-2021 ยท ILI Sling, Arm
DJ Orthopedics de Mexico S.A. de C.V.
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.
| Date | Apr 12, 2021 |
| Status | Terminated |
| Reason | failed rivet at the chafe tab of arm sling. |
| Root cause | Under Investigation by firm |
| Action | On 4/12/21, DJO, LLC sent a ""Urgent: Medical Device Recall" letter via UPS to all affected consignees. In addition to informing consignees about the recall, the firm asked customer to take the following actions: 1.DJO, LLC is recommending to review, quarantine, and discontinue use all product in your inventory from the above list. 2. Please contact customer service for immediate replacement of unused inventory at 1 800 336 6569 or Customer.Care@DJOGlobal.com. 3. If you are an OfficeCare account, please contact OfficeCare customer service for immediate replacement of unused inventory at 1 8 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.