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U.S. Department of Health and Human Services

Class 2 Device Recall UltraSling Pro

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 Class 2 Device Recall UltraSling Prosee related information
Date Initiated by FirmApril 12, 2021
Create DateApril 29, 2021
Recall Status1 Terminated 3 on March 21, 2024
Recall NumberZ-1512-2021
Recall Event ID 87727
Product Classification Sling, arm - Product Code ILI
ProductDONJOY 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.
Code Information Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18
FEI Number 3017264244
Recalling Firm/
Manufacturer		 DJ Orthopedics de Mexico S.A. de C.V.
Carretera Libre Tijuana-Tecate
20230 Submetropoli El Florido
Tijuana Mexico
Manufacturer Reason
for Recall		failed rivet at the chafe tab of arm sling.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
DistributionWorldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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