Ossur recalls Miami J Select Collar (MJS-101) and Set (MJSR-101) due to updated instructions for use. No safety hazard exists; this is a routine update to improve user guidance.
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Ossur is recalling the Miami J Select Collar (MJS-101) and Set (MJSR-101) because their instructions for use were updated in 2018. This recall does not involve any safety hazard—it's just a routine update to help users select and use the device properly.
The recall involves updated instructions for use that were released in 2018. There is no safety hazard—this is a routine update to improve how users select and use the collar device. The hazard is purely informational and does not affect safety.
Users of the Miami J Select Collar (MJS-101) and Set (MJSR-101) who have the 2018 updated instructions for use are affected. People with neck support devices are most at risk if they rely on outdated instructions.
Check for the Miami J Select Collar (MJS-101) or Set (MJSR-101) with the 2018 updated instructions for use. The product is sold by Ossur Americas.
Check if your collar or set has the 2018 updated instructions for use.
No, this recall is not dangerous. It's a routine update to the instructions for use with no safety hazard.
No, you do not need to stop using it. This is just an update to the instructions for use.
No action is needed. The recall is informational only and does not require discarding or returning the product.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-0380-2022 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-0380-2022 from Ossur. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
