Miami J Select Collar Recalled Due to Adhesive Failure
Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with documented adhesive failure that could result in loss of spinal immobilization function. While no illnesses or injuries have been reported, the potential loss of function in a protective orthotic device meets the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Miami J Select Collar and Miami J Select Collar Set, manufactured by Ossur H/F, are being recalled due to adhesive failure affecting the attachment of pressure-sensitive hooks on the collar panel.
The hooks are designed to help maintain cervical spine immobilization. In some units, the adhesive holding these hooks to the collar sides exhibits poor adhesion and may gradually peel off with repeated use of the collar, potentially reducing its ability to properly immobilize the cervical spine.
Approximately 21,020 units have been distributed across the United States and Puerto Rico. The affected products were manufactured and sold between May 2022 and June 2023.
Consumers who have purchased affected units should stop using the collar and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
- Manufacturer
- Ossur H / F
- Affected units
- 21,020
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 (3)
- REF/UDI-DI/GTIN/Lot Range/Sold in the Period
- Date Range: MJS-101/05690967817008/MX220516 to MX230104/2022-05-19 to 2023-06-05
- MJSR-101/05690967817145/MX220516 to MX230104/2022-05-19 to 2023-06-05
Distribution
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