Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1003-2019·Announced 2019-03-20

Ossur ReSolve Halo Vest Recalled for Labeling and Safety Testing Issues

Ossur Americas is recalling 381 ReSolve Halo Vests because the titanium pin label incorrectly lists a ceramic tip and the products require confirmatory safety testing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error and the need for confirmatory safety testing, which aligns with the rubric for moderate severity involving minor labeling errors or precautionary measures.

Plain-English summary

Ossur Americas is recalling 381 units of the ReSolve Halo Vest. The recall involves specific short and tall sizes made of kodel and lambwool materials. The affected products were manufactured between June 30, 2009, and December 13, 2018.

The recall was initiated because the second line of the description on the titanium pin label mistakenly lists a ceramic tip, whereas it should state titanium pin. Additionally, Halo system products labeled as MR conditional will undergo confirmatory safety testing to verify their MR conditional parameters.

The products were distributed in 30 U.S. states and in Australia, Germany, New Zealand, and Belgium. Consumers who have these products should contact Ossur Americas for instructions on the confirmatory safety testing and label correction.

The recalled product

Product: 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
Manufacturer: Ossur Americas
Category: Medical Device — Orthopedic / Halo Vest
Hazard: mis-labeling
safety-testing
Affected units: 381

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 28 states:

Part of a larger recall action

This product is one of 8 recalled by Ossur Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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