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Terminated

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

FDA Recall Z-0380-2022 · Posted None

Recalling FirmOssur Americas
Recall StatusTerminated
Product CodeIQK
Date Initiated2021-11-09
Date Terminated2023-12-18

Reason for Recall

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

Firm 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

Root Cause

Labeling Change Control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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