Ossur Halo System Ring Kits Recalled for Labeling and Safety Testing
Ossur Americas is recalling 182 units of Halo system ring kits due to a labeling error and the need for confirmatory safety testing.
What this means for you
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The specific issues are a labeling error and the need for confirmatory testing, with no reported injuries or illnesses in the source text.
Plain-English summary
Ossur Americas is recalling 182 units of sterile Halo system ring kits and component trays. The recall involves specific part numbers including CB and OB V2 ring kits in small, standard, and large sizes, as well as sterile titanium component trays. The affected products were manufactured between June 30, 2009, and December 13, 2018.
The recall was initiated because Halo system products labeled as MR conditional will undergo confirmatory safety testing to verify their MR conditional parameters. Additionally, a labeling error was identified where the second line of the titanium pin label mistakenly lists 'ceramic tip' instead of the correct description, 'titanium pin.'
The products were distributed in the United States to hospitals and clinics in 30 states, including California, Texas, and New York, as well as in Australia, Germany, New Zealand, and Belgium. Healthcare providers and patients should contact Ossur Americas for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB
- Manufacturer
- Ossur Americas
- Affected units
- 182
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
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.
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