Ossur CB Resolve Halo System Recalled for Labeling and Testing Issues
Ossur Americas is recalling 656 units of CB Resolve Halo system products 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, but the source text describes a labeling error and a requirement for confirmatory testing without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ossur Americas is recalling 656 units of Ossur CB Resolve, Sterile, Halo system products. The recall covers various sterile units, ring kits, component trays, and closed back halo kits manufactured between June 30, 2009, and December 13, 2018.
The recall was initiated because the products are labeled as MR conditional but require confirmatory safety testing to verify these parameters. Additionally, a labeling error was identified on the titanium pin, where the second line description incorrectly lists a ceramic tip instead of stating titanium pin.
The affected products were distributed in 30 U.S. states and in Australia, Germany, New Zealand, and Belgium. Consumers and healthcare providers should stop using these products and contact Ossur Americas for further instructions.
The recalled product
- Product
- Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT
- Manufacturer
- Ossur Americas
- Affected units
- 656
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.
See all 8 products in this recall →Related recalls
Same manufacturer · Ossur Americas
See all →- HighOSSUR Power Knee Prosthetics Recalled for Battery Dislodgement Risk
FDA (Devices) · 2022-10-05
- HighOssur Variflex Suba Junior prosthetic foot may crack under impact
FDA (Devices) · 2022-07-13
- HighFDA Updates Instructions for Miami J Select Collar Device
FDA (Devices) · 2021-12-22
- HighOSSUR Miami J Select Collar Recalled for Deforming Height-Adjustment Racks
FDA (Devices) · 2021-06-23
- ModerateOssur Skull Pin Recall Due to Labeling Error and Safety Testing
FDA (Devices) · 2019-03-20
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02