FDA Medical Device Recalls (openFDA)
Ossur Americas: Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
- Recall number
- Z-0380-2022
- Recalling firm
- Ossur Americas
- Product
- Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
- Status
- Terminated
- Initiated
- 2021-11-09
- Posted
- not on file
- Terminated
- 2023-12-18
- Reason
- Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
- Root 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
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Instructions for Use Rev. 3 2018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQK
- Firm FEI
- 1000519909
- Firm city
- Foothill Ranch
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28