FDA Updates Instructions for Miami J Select Collar Device
Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.
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: This is an FDA Class II recall involving an instruction deficiency for a medical device. Although no injuries have been reported, inadequate instructions for use of a cervical collar pose a risk of harm through improper device selection or application. This meets the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Miami J Select Collar, Item MJS-101, and Miami J Select Collar Set, Item MJSR-101, are subject to an update of their Instructions for Use (IFU Revision 3, 2018). Ossur Americas, the manufacturer, updated the instructions to include additional information to facilitate proper selection and use of the collar device.
The affected devices were distributed nationwide across the United States. Consumers who have these devices should review and follow the updated instructions to ensure correct device selection and application.
No injuries or adverse health events have been reported in connection with the instruction update. The update is intended to clarify guidance and prevent potential misuse of the device.
The recalled product
- Product
- Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
- Manufacturer
- Ossur Americas
- Hazard
- instruction-deficiency
- improper-use-risk
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)
- Instructions for Use Rev. 3 2018
Distribution
Distributed nationwide across the United States.
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