Ossur H F Grjothals 5 Reykjavik Iceland Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Brand
Ossur H F Grjothals 5 Reykjavik Iceland
Lot Codes / Batch Numbers
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
Products Sold
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
Ossur H F Grjothals 5 Reykjavik Iceland is recalling Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 due to Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 acknowledgements@ossur.com Contact customer service at this phone number for further information and assistance: Tel: 800-233-6263
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, PR
Page updated: Jan 10, 2026