Z-1513-2021Class II

DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 -

Name: Z-1513-2021 DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 -
Creator: DJ Orthopedics de Mexico S.A. de C.V.
Published: 2021-04-12
License: https://open.fda.gov/license/

DJO, LLC / initiated 2021-04-12 / Terminated

FDA source

DJ Orthopedics de Mexico S.A. de C.V. began a recall of 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... on 2021-04-12. FDA classified it as Class II and gives the reason as "failed rivet at the chafe tab of arm sling". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1513-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-12
Posted: 2021-04-29
Terminated: 2024-03-21
Recalling firm: DJO, LLC
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.
Product code: ILI Sling, Arm
Reason for recall: failed rivet at the chafe tab of arm sling.
FDA 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 [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.
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Product codes and lots: Lot Numbers: 2021-01-05, 2021-01-20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1513-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1511-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29
Z-1512-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29
Z-1513-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29
Z-1514-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29

Product code ILI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)