Recall Z-0006-2025 ยท IQK Orthosis, Cervical
Ossur H / F
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
| Date | Oct 1, 2024 (initiated Aug 20, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 v |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.