CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report

Ossur, ReSolve Halo Vest, Part/ Description recalled by Ossur Americas

Ossur Americas is recalling Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel, distributed in 28 states. The recall was initiated on 21 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots of the products manufactured from 06/30/2009 - 12/13/2018

Quantity recalled381

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1003-2019
FDA event ID: 80520
Recalling firm: Ossur Americas, Foothill Ranch, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Jun 2018
FDA classified: 11 Mar 2019
Reported: 20 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Jun 2018	Recall initiated by company
11 Mar 2019	Classified by FDA	+263 days
20 Mar 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Product as listed by the FDA

Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool

Where it was distributed

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

Alaska Alabama Arizona California Delaware Florida Georgia Hawaii Illinois Indiana Kentucky Massachusetts Michigan Minnesota Mississippi North Carolina Nebraska New Mexico New York Ohio

Questions about this recall

Is Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel recalled?

Yes. Ossur Americas recalled Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel on 21 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-1003-2019.

Why was it recalled?

Which lots are affected?

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Where was it sold?

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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