Reported May 5, 2021 · Terminated

DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended…

DJ Orthopedics de Mexico S.A. de C.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DJ Orthopedics de Mexico S.A. de C.V. · Carretera Libre Tijuana-Tecate · Tijuana, N/A · N/A

Is this the product you have?

  • DONJOY REF11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY
  • UDI(01) 00190446683667 -
  • Product Usageintended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck
Lot codes and dates
  • 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
Amount recalled
N/A

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

failed rivet at the chafe tab of arm sling.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 21, 2024 · Data as of Sep 19, 4:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.