Class 2 Device Recall Miami J Select Model: MJS101, MJSR101

• Date Initiated by Firm: November 09, 2021
• Create Date: December 15, 2021
• Recall Status: Terminated on December 18, 2023
• Recall Number: Z-0380-2022
• Recall Event ID: 89014
• Product Classification: Orthosis, cervical - Product Code IQK
• Product: Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
• Code Information: Instructions for Use Rev. 3 2018
• 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: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
• FDA Determined Cause: Labeling Change Control
• Action: On 11/09/21, Field Safety Notices and updated Instructions for Use, Rev. 6 2021, were emailed to customers. Customers were asked to take the following actions: 1.Please ensure the updated Instructions for Use are distributed to the necessary persons within the organization and that they are adhered to when selecting and using the Miami J Select device. A copy of the updated instructions accompanies this notice. 2.Please pass this notice to those who need to be aware within your organization or to any organization where the listed devices have been transferred. 3.Please retain this letter in a prominent position for one month. 4.If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 5.Reply to the email that you received confirming receipt of this notice and the updated instructions for use, even if your facility is no longer in possession of affected devices. Customers are encouraged to contact customer service for further information and assistance: U.S. 1-800-233-6263
• Distribution: US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.
• 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.