Unrated Medical device recall · FDA · Published April 12, 2021

DONJOY ULTRASLING PRO ER/IR 30 Sling: Failed Rivet Risk

DJ Orthopedics recalls specific DONJOY ULTRASLING PRO ER/IR 30 arm slings with a failed rivet at the chafe tab, which could cause injury during use. Affected units have UDI (01)00190446683674 and were sold in 2021.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1513-2021Medical device DJ Orthopedics ›

Recall notice

failed rivet at the chafe tab of arm sling.

Take action

Contact the company

Recalling firmDJ Orthopedics de Mexico S.A. de C.V.Carretera Libre Tijuana-Tecate, 20230 Submetropoli El Florido · Tijuana, Mexico

✎ GovInfoNow plain-language explainer

DJ Orthopedics recalls certain DONJOY ULTRASLING PRO ER/IR 30 arm slings due to a failed rivet at the chafe tab that could cause injury. This affects medical slings sold in 2021 with specific UDI numbers. Read more at govinfonow.com/recall/62794-donjoy-ultrasling-pro-er-ir-30-sling-failed-rivet-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62794-donjoy-ultrasling-pro-er-ir-30-sling-failed-rivet-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1513-2021

Cite this page

“DONJOY ULTRASLING PRO ER/IR 30 Sling: Failed Rivet Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62794-donjoy-ultrasling-pro-er-ir-30-sling-failed-rivet-risk. Based on FDA recall #Z-1513-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1513-2021%22&limit=1).

The FDA announced on April 12, 2021, that DJ Orthopedics de Mexico S.A. de C.V. is recalling DONJOY ULTRASLING PRO ER/IR 30 arm slings due to a failed rivet at the chafe tab. The agency classified this as a Class II recall.

How to tell if you have it

Brand: DJ Orthopedics
Product: DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY
UDI: (01)00190446683674
UPC: 00190446683674
Lot Numbers: 2021-01-05, 2021-01-20

The hazard

The recall is due to a failed rivet at the chafe tab of the arm sling. The product is intended for medical purposes to immobilize the arm by means of a fabric band suspended from around the neck.

How to tell if you have this one

Check for the UDI (01)00190446683674 on the product. The slings were sold in 2021 with lot numbers 2021-01-05 and 2021-01-20.

Brand
DJ Orthopedics
Product
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

Recall number	Product, codes & lots
Z-1511-2021	DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.; Lot Numbers: 2020-11-17, 2020-11-28, 2020-11-29, 2020-11-30, 2020-12-02, 2020-12-07, 2020-12-09, 2020-12-10, 2020-12-11, 2020-12-12, 2020-12-13, 2021-01-12, 2021-01-13, 2021-01-14, 2021-01-15, 2021-01-20, 2021-02-02, 2021-02-03, 2021-02-04, 2021-02-05, 2021-02-09, 2021-02-11, 2021-02-12, 2021-02-13, 2021-02-14, 2021-02-15, 2021-02-16, 2021-02-21, 2021-02-22, 2021-02-23, 2021-02-24, 2021-02-25, 2021-02-27, 2021-02-28, 2021-03-01, 2021-03-02, 2021-03-03, 2021-03-04, 2021-03-09, 2021-03-10, 2021-03-11, 2021-03-12, 2021-03-13, 2021-03-18, 2021-03-19
Z-1512-2021	DONJOY 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.; 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
Z-1513-2021	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.; Lot Numbers: 2021-01-05, 2021-01-20
Z-1514-2021	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.; Lot Numbers: 2021-01-05, 2021-01-20, 2021-03-10, 2021-03-11, 2021-03-16

Based on the official FDA remedy

What to do — step by step

Check UDI Number
Look for the UDI (01)00190446683674 on the product to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

Apr 12, 2021Firm started the recall
Apr 29, 2021FDA classified it Class II
May 5, 2021Published in FDA’s Enforcement Report
Mar 21, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More DJ Orthopedics recalls

Link to this recall

<a href="https://govinfonow.com/recall/62794-donjoy-ultrasling-pro-er-ir-30-sling-failed-rivet-risk">DONJOY ULTRASLING PRO ER/IR 30 Sling: Failed Rivet Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1513-2021 (April 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1513-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.