Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Summary
The FDA issued a Class II for Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR- by Ossur Americas. Reason: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device..
Details
Source
Device Recall
External ID
Z-0380-2022
Action Date
2021-12-22
Status
Terminated
Category
device
Product Description
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Lot/Code Info: Instructions for Use Rev. 3 2018
Reason for Recall
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-09
Company
Foothill Ranch, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ossur Americas has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ossur Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ossur Americas have FDA actions?
Ossur Americas has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0380-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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