FDA Medical Device Recalls (openFDA)
DJ Orthopedics de Mexico S.A. de C.V.: DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
- Recall number
- Z-1514-2021
- Recalling firm
- DJ Orthopedics de Mexico S.A. de C.V.
- Product
- DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
- Status
- Terminated
- Initiated
- 2021-04-12
- Posted
- not on file
- Terminated
- 2024-03-21
- 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 1 866 238 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.
- Quantity
- not on file
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
- Lot, serial or model codes
- Lot Numbers: 2021-01-05, 2021-01-20, 2021-03-10, 2021-03-11, 2021-03-16
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILI
- Firm FEI
- 3017264244
- Firm city
- Tijuana
- Firm state
- not on file
- Firm country
- Mexico
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28