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U.S. Department of Health and Human Services

Class 2 Device Recall Miami J Select Collar

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 Class 2 Device Recall Miami J Select Collarsee related information
Date Initiated by FirmAugust 20, 2024
Date PostedOctober 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0006-2025
Recall Event ID 95278
Product Classification Orthosis, cervical - Product Code IQK
ProductMiami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Code Information 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
Recalling Firm/
Manufacturer		 Ossur H / F
Grjothals 5
Reykjavik Iceland
For Additional Information Contact
3545151300
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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
Quantity in Commerce21,020
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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