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.
FDA Recall Z-1513-2021 · Posted None
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Recalling FirmDJ Orthopedics de Mexico S.A. de C.V.
Recall StatusTerminated
Product CodeILI
Date Initiated2021-04-12
Date Terminated2024-03-21
Reason for Recall
failed rivet at the chafe tab of arm sling.
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 [email protected].
3. If you are an OfficeCare account, please contact OfficeCare customer service for immediate replacement of unused inventory at 1 866 238 0398 or [email protected].
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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