Class 2 Device Recall OSSUR MIAMI J SELECT COLLAR

• Date Initiated by Firm: June 01, 2021
• Create Date: June 17, 2021
• Recall Status: Terminated on June 22, 2023
• Recall Number: Z-1896-2021
• Recall Event ID: 88075
• Product Classification: Orthosis, cervical - Product Code IQK
• Product: OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine.; ; REF:; MJS-101;; MJSR-101
• Code Information: REF Number: MJS-101; MJSR-101. Lot Numbers: MX180425 through MX200306
• Recalling Firm/ Manufacturer: Ossur Americas; 27051 Towne Centre Dr; Foothill Ranch CA 92610-2804
• For Additional Information Contact: Scott Brandon Powis; 800-233-6263 Ext. 3892
• Manufacturer Reason for Recall: Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
• FDA Determined Cause: Device Design
• Action: On 06/01/2021, the Recalling Firm emailed or called its customers and provided an "URGENT MEDICAL DEVICE RECALL" letter informing them that it had identified that cervical collars may deform under certain conditions, possibly leading to reduced immobilization of the cervical spine. The likelihood of deformation is higher when in use at higher height configurations. Further, the risk of deformation increases with the number of days the device is worn. Customers are instructed to: -Examine their inventory, quarantine products subject to the recall, and return the Customer Acknowledgement Form to the email address listed on the form. A return authorization will then be provided to return the product to the Recalling Firm. Additional actions to take: 1. Pass this notice to those who need to be aware within the customer's organization or to any organization where the potentially affected devices has been transferred. 2. Maintain awareness on this notice for an appropriate period. 3. If the affected products have been further distributed, identify the customers, and notify them at once of this recall. The Recalling Firm recommends including a copy of this recall letter. 4. The Recalling Firm recommends healthcare professionals perform a detailed inspection of the device to verify lot number, and to ensure proper fit and structural stability for any patients current wearing impacted product. 5. If any customers are currently wearing a product, the packaging label should be inspected for the lot number (Note: The number inside the collar is not the lot number; that is the device serial 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, healthcare professionals are advised to assess whether a removal and replacement of impacted product currently in use is warranted on a case-by-case basis. " If the packaging label/lot number is not available, healthcare professionals a
• Quantity in Commerce: 10,469 items
• Distribution: U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Not provided.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.