Reported Jun 23, 2021 · Terminated

OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF:…

Ossur Americas

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: Ossur Americas · 27051 Towne Centre Dr · Foothill Ranch, CA · 92610-2804

Is this the product you have?

  • OSSUR
  • MIAMI J SELECT COLLAR - Product Usageis intended to provide gross immobilization to the cervical spine
  • REF
    • MJS-101
    • MJSR-101
Lot codes and dates
  • REF Number
    • MJS-101
    • MJSR-101
  • Lot NumbersMX180425 through MX200306
Amount recalled
10,469 items

Where it was sold

Why it was recalled

Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 22, 2023 · Data as of Sep 19, 5:41 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.