OSSUR Miami J Select Collar Recalled for Deforming Height-Adjustment Racks
Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.
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 3/5 (High).
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: This is a Class II FDA recall for a critical medical device with a structural defect (deforming racks) that directly compromises its intended immobilization function. While no injuries have been reported, this qualifies as a risk-of-harm product where the hazard is significant given the device's critical role in cervical spine support.
Plain-English summary
Ossur Americas is recalling the MIAMI J SELECT COLLAR, a cervical spine immobilization device (model references MJS-101, MJSR-101). The device contains racks associated with height adjustment functionality that have insufficient column strength for all load conditions.
The height-adjustment racks have been observed deforming due to inadequate column strength. This deformation may lead to increased range of motion in the cervical spine, compromising the device's ability to provide proper immobilization.
Approximately 10,469 devices have been recalled. The affected units were distributed nationwide throughout the United States, including all states and Puerto Rico, with lot numbers MX180425 through MX200306.
The recalled product
- Product
- OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
- Manufacturer
- Ossur Americas
- Affected units
- 10,469
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 (2)
- REF Number: MJS-101
- MJSR-101. Lot Numbers: MX180425 through MX200306
Distribution
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