Z-0006-2025Class II

Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Name: Z-0006-2025 Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Creator: Ossur H / F
Published: 2024-08-20
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2024-08-20 / Open, Classified / root cause: manufacturing process

FDA source

Ossur H / F began a recall of Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 on 2024-08-20. FDA classified it as Class II and gives the reason as "Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0006-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-20
Posted: 2024-10-01
Recalling firm: Ossur Iceland ehf.
Product: Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Product code: IQK Orthosis, Cervical
Reason for recall: Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 8/20/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Pass this notice to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 2) Maintain awareness on this notice for an appropriate period. 3) If you have further distributed this device, please identify your customers, and notify them at once of this recall. We recommend that you include a copy of this recall letter. 4) Firm recommends healthcare professionals perform a detailed inspection of the device to verify lot number, and to ensure structural stability for any patients currently wearing impacted device. 5) If any of your customers are currently wearing a device, the packaging label and product label should be inspected for the lot number: -If the lot number is outside of the affected range, no actions need to be taken. -If the lot number is inside the affected range or if the packaging label or lot number on the product label is not available, healthcare professionals are advised to contact customer service for replacement device. 6) Complete and return the acknowledgement form via email to [email protected] Contact customer service at this phone number for further information and assistance: Tel: 800-233-6263
Quantity in commerce: 21,020
Distribution: US: NH, MA, NY, NJ, PA, GA, MD, NC, IN, FL, AR, TN, KY, OH, MI, IL, TX, MO, CO, UT, AZ, WA, OR, CA, NM, VA, IA, MN, NE, SC, MT, LA, ID, SD, AL, CT, OK, AK, PR
Product codes and lots: REF/UDI-DI/GTIN/Lot Range/Sold in the Period, Date Range: MJS-101/05690967817008/MX220516 to MX230104/2022-05-19 to 2023-06-05, MJSR-101/05690967817145/MX220516 to MX230104/2022-05-19 to 2023-06-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0006-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0006-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-10-01

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)