CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report

Miami J Collar recalled by Ossur H / F

Ossur H / F is recalling Miami J Collar, distributed in 48 states. The recall was initiated on 24 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem No: MJ-200B MJ-200L MJ-200LFRT MJ-200S MJ-200SFRT MJ-250 MJ-250FRT MJ-2530 MJ-300 MJ-300FRT MJ-400 MJ-400FRT MJ-500 MJ-500FRT MJ-P2 MJ-P3 MJR-200L MJR-200S MJR-250 MJR-2530 MJR-300 MJR-400 MJR-500 MJR-P2 MJR-P3

Quantity recalled15,825

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-1288-2016
FDA event ID: 73380
Recalling firm: Ossur H / F, Reykjavik, N/A
Classification: Class II
Status: Terminated
Recall initiated: 24 Feb 2016
FDA classified: 31 Mar 2016
Reported: 6 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Feb 2016	Recall initiated by company
31 Mar 2016	Classified by FDA	+36 days
6 Apr 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p

Product as listed by the FDA

Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.

Where it was distributed

U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

Item No: MJ-200B MJ-200L MJ-200LFRT MJ-200S MJ-200SFRT MJ-250 MJ-250FRT MJ-2530 MJ-300 MJ-300FRT MJ-400 MJ-400FRT MJ-500 MJ-500FRT MJ-P2 MJ-P3 MJR-200L MJR-200S MJR-250 MJR-2530 MJR-300 MJR-400 MJR-500 MJR-P2 MJR-P3

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 73380

This product is part of a recall event; the main page for the event is Rebound Air Walker recalled by Ossur H / F.

Reported	Class	Recall	Company	Reason	Where
6 Apr 2016	CLASS II	Rebound Air Walker recalled by Ossur H / F	Ossur H / F	Other	48 states
6 Apr 2016	CLASS II	Unloader Custom Lite recalled by Ossur H / F	Ossur H / F	Potency & Assay	48 states
6 Apr 2016	CLASS II	Papoose Infant Spine Immobilizer recalled by Ossur H / F	Ossur H / F	Other	48 states
6 Apr 2016	CLASS II	Rebound Cartilage Custom recalled by Ossur H / F	Ossur H / F	Potency & Assay	48 states
6 Apr 2016	CLASS II	Rebound Cartilage recalled by Ossur H / F	Ossur H / F	Potency & Assay	48 states
6 Apr 2016	CLASS II	Knee Undersleeve Gray recalled by Ossur H / F	Ossur H / F	Other	48 states
6 Apr 2016	CLASS II	Back Support Suspenders Clip on Black Back Support recalled	Ossur H / F	Other	48 states
6 Apr 2016	CLASS II	Unloader XT recalled by Ossur H / F	Ossur H / F	Potency & Assay	48 states
6 Apr 2016	CLASS II	Extreme Custom recalled by Ossur H / F	Ossur H / F	Potency & Assay	48 states
6 Apr 2016	CLASS II	NecLoc Extrication Collar recalled by Ossur H / F	Ossur H / F	Other	48 states
6 Apr 2016	CLASS II	Unloader Custom recalled by Ossur H / F	Ossur H / F	Potency & Assay	48 states
6 Apr 2016	CLASS II	Rebound Diabetic Walker recalled by Ossur H / F	Ossur H / F	Other	48 states
6 Apr 2016	CLASS II	Knee Shield (Patella Cup) recalled by Ossur H / F	Ossur H / F	Other	48 states

More recalls from Ossur H / F

All 29

Reported	Class	Recall	Company	Reason	Where
9 Oct 2024Device	CLASS II	Miami J Select Collar recalled by Ossur H / F	Ossur H / F	Other	39 states
22 May 2024Device	CLASS II	RKN130003, Rheo Knee 3 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide
22 May 2024Device	CLASS II	RKNXC0003, Rheo Knee XC 3 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide
22 May 2024Device	CLASS II	RKNXC0005, Rheo Knee XC 5 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide
22 May 2024Device	CLASS II	RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide