DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico
Lot Codes / Batch Numbers
Lot Numbers: 2021-01-05, 2021-01-20
Products Sold
Lot Numbers: 2021-01-05, 2021-01-20
DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico is recalling DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product due to failed rivet at the chafe tab of arm sling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
failed rivet at the chafe tab of arm sling.
Recommended Action
Per FDA guidance
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 1 866 238 0398 or OfficeCareLogistics@DJOGlobal.com. 4. Please notify patients that have been dispensed a product from the above list, to return the product for replacement. 5. Please complete the return response included with this letter to the contact person identified on the response form below, no later than NOVEMBER 30, 2021. In addition, please complete the response form even if you no longer have any of the devices on hand.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026