Recall Z-0380-2022— Ossur Americas
Class II · Terminated
Class II FDA medical device recall by Ossur Americas, initiated 2021-11-09, terminated 2023-12-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use. Reason: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device..
- Recalling firm
- Ossur Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-09
- Terminated
- 2023-12-18
- Firm location
- Foothill Ranch, CA, United States
Product description
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Reason for recall
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.