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

FDA device recall Z-0006-2025 · posted 2024-10-01 · Open, Classified

Recall details

Recalling firm

Ossur H / F

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

IQK

Quantity affected

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

Date initiated

2024-08-20

Date posted

2024-10-01

Location

Reykjavik, Iceland