Lower riskMedical device recall · FDA · Published November 9, 2021
Ossur Miami J Select Collar Recall: Updated Instructions for Use
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.
“Ossur Miami J Select Collar Recall: Updated Instructions for Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61557-ossur-miami-j-select-collar-recall-updated-instructions-for-use. Based on FDA recall #Z-0380-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0380-2022%22&limit=1).
Ossur Americas recalled Miami J Select Collar and Miami J Select Collar Set Instructions for Use because the documents were updated to include additional information to facilitate selection and use, according to the FDA. The Food and Drug Administration announced the recall on November 9, 2021.
The recall addresses Instructions for Use that were updated to include additional information to facilitate the selection and use of the collar device.
Context
GovInfoNow's records show Ossur Americas has 4 other recalls on record since June 21, 2018. Other recent recalls include the Power Knee Recall (August 29, 2022) and the VARIFLEX SUBA JUNIOR Prosthetic Foot Recall (May 30, 2022). Ossur also issued a Miami J Select Collar Recall on June 1, 2021, regarding deforming racks.
How to tell if you have this one
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.
Brand
Ossur
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Instructions
Check if your collar or set has the 2018 updated instructions for use.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 46 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0380-2022 (November 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0380-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.