CLASS II Device recall · Reported 22 Dec 2021 · FDA Enforcement Report
Miami J Select Collar recalled by Ossur Americas
Ossur Americas is recalling Miami J Select Collar, distributed nationwide in the US. The recall was initiated on 9 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0380-2022
- FDA event ID
- 89014
- Recalling firm
- Ossur Americas, Foothill Ranch, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2021
- FDA classified
- 15 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Nov 2021 | Recall initiated by company | |
| 15 Dec 2021 | Classified by FDA | +36 days |
| 22 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Product as listed by the FDA
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Miami J Select Collar recalled?
Yes. Ossur Americas recalled Miami J Select Collar on 9 Nov 2021. The recall is Class II and its status is Terminated. Recall number Z-0380-2022.
Why was it recalled?
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Which lots are affected?
Instructions for Use Rev. 3 2018
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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