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OSSUR AMERICAS

Last updated September 17, 2026

Information

Country: US
Address: 680 Grove Rd, West Deptford, NJ, 08086
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2242474
DUNS Number: —

Catalogue (253)

Page 2 of 6

Device	Model / Reference	Registries	Class	Status
Cold Rush	B-232602100	FDA UDI	Class II	Active
Cold Rush	B-232000017	FDA UDI	Class II	Active
Halo Systems	JT-400	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5233	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5293	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4303	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU8273	FDA UDI	Class II	Unknown
Halo Systems	505500D	FDA UDI	Class II	Unknown
Symbionic Leg	SBL13110	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4293	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE8283	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU7273	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100014	FDA UDI	Class II	Active
Halo Systems	516TS	FDA UDI	Class II	Unknown
Dvt	DVT52000	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100010	FDA UDI	Class II	Active
Halo Systems	554CB	FDA UDI	Class II	Unknown
Power Knee	PKA10003	FDA UDI	Class I	Active
Halo Systems	JT-110	FDA UDI	Class II	Unknown
Power Knee	PKN120017	FDA UDI	Class II	Unknown
Halo Systems	505301C	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5283	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU6303	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5273	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3223	FDA UDI	Class II	Unknown
Cold Rush	B-232502100	FDA UDI	Class II	Active
Halo Systems	505400T	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3233	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5243	FDA UDI	Class II	Unknown
Halo Systems	520V2S	FDA UDI	Class II	Unknown
Cold Rush	B-232002404	FDA UDI	Class II	Active
Dvt	MDSDVT62203	FDA UDI	Class II	Unknown
Halo Systems	553CB	FDA UDI	Class II	Unknown
Halo Systems	555CB	FDA UDI	Class II	Unknown
Cold Rush	B-232000014	FDA UDI	Class II	Active
Symbionic Leg	SMBE4223	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5263	FDA UDI	Class II	Unknown
Halo Systems	515C4	FDA UDI	Class II	Unknown
Halo Systems	517CS	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU3293	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4243	FDA UDI	Class II	Unknown
Rheo Knee	RKN130005	EUDAMEDFDA UDI	Class I	Active
Power Knee	PKN120007	FDA UDI	Class II	Unknown
Rheo Knee	RKNXC0003	EUDAMEDFDA UDI	Class I	Active
Symbionic Leg	SMBE7253	FDA UDI	Class II	Unknown
Halo Systems	520TS	FDA UDI	Class II	Unknown
Rheo Knee	RKN13130	EUDAMEDFDA UDI	Class I	Active
Symbionic Leg	SMBU2283	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU1233	FDA UDI	Class II	Unknown

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 29, 2022	Z-1821-2022	—	open, classified	Battery may dislodge from the Power Knee
May 30, 2022	Z-1330-2022	—	terminated	Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.
Nov 9, 2021	Z-0380-2022	—	terminated	Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Jun 1, 2021	Z-1896-2021	—	terminated	Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
Jun 21, 2018	Z-1004-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-1001-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-1002-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-0999-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-1003-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-1000-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-0997-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Jun 21, 2018	Z-0998-2019	—	terminated	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Oct 15, 2012	Z-1097-2014	—	terminated	OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
Feb 12, 2012	Z-0936-2014	—	terminated	OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.