Z-0380-2022Class II

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Name: Z-0380-2022 Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Creator: Ossur Americas
Published: 2021-11-09
License: https://open.fda.gov/license/

Ossur Americas / initiated 2021-11-09 / Terminated / root cause: labeling and UDI

FDA source

Ossur Americas began a recall of Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use on 2021-11-09. FDA classified it as Class II and gives the reason as "Instructions for use were updated to include additional information to facilitate the selection and use of the collar device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0380-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-09
Posted: 2021-12-15
Terminated: 2023-12-18
Recalling firm: Ossur Americas
Product: Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Product code: IQK Orthosis, Cervical
Reason for recall: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 11/09/21, Field Safety Notices and updated Instructions for Use, Rev. 6 2021, were emailed to customers. Customers were asked to take the following actions: 1.Please ensure the updated Instructions for Use are distributed to the necessary persons within the organization and that they are adhered to when selecting and using the Miami J Select device. A copy of the updated instructions accompanies this notice. 2.Please pass this notice to those who need to be aware within your organization or to any organization where the listed devices have been transferred. 3.Please retain this letter in a prominent position for one month. 4.If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 5.Reply to the email that you received confirming receipt of this notice and the updated instructions for use, even if your facility is no longer in possession of affected devices. Customers are encouraged to contact customer service for further information and assistance: U.S. 1-800-233-6263
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.
Product codes and lots: Instructions for Use Rev. 3 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0380-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0380-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-15

Product code IQK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)