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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 1 of 6

Device	Model / Reference	Registries	Class	Status
Symbionic Leg	SMBE2273	FDA UDI	Class II	Unknown
Halo Systems	515400C	FDA UDI	Class II	Unknown
Power Knee	PKA01001L	EUDAMEDFDA UDI	Class I	Active
Symbionic Leg	SMBE8293	FDA UDI	Class II	Unknown
Cold Rush	B-232002204	FDA UDI	Class II	Active
Cold Rush Compact	B-232100017	FDA UDI	Class II	Active
Halo Systems	538	FDA UDI	Class I	Unknown
Rheo Knee	RKNXC230	EUDAMEDFDA UDI	Class I	Active
Symbionic Leg	SBL12102	FDA UDI	Class II	Unknown
Halo Systems	505401C	FDA UDI	Class II	Unknown
Rheo Knee	RKN13110	FDA UDI	Class I	Active
Symbionic Leg	SMBU3243	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4263	FDA UDI	Class II	Unknown
Cold Rush	B-232002300	FDA UDI	Class II	Active
Symbionic Leg	SMBU8253	FDA UDI	Class II	Unknown
Symbionic Leg	SBL13210	FDA UDI	Class II	Unknown
Halo Systems	505400D	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4253	FDA UDI	Class II	Unknown
Cold Rush	B-232000016	FDA UDI	Class II	Active
Dvt	DVT62204	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE1253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU6273	FDA UDI	Class II	Unknown
Dvt	DVT62201	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE2223	FDA UDI	Class II	Unknown
Halo Systems	JT-210	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU2233	FDA UDI	Class II	Unknown
Halo Systems	515500C	FDA UDI	Class II	Unknown
Power Knee	PKN12100	FDA UDI	Class II	Unknown
Halo Systems	505300V2	FDA UDI	Class II	Unknown
Halo Systems	JT-100	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU3273	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4223	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4243	FDA UDI	Class II	Unknown
Halo Systems	525C	FDA UDI	Class II	Unknown
Halo Systems	515500V2	FDA UDI	Class II	Unknown
Halo Systems	JT-200	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4273	FDA UDI	Class II	Unknown
Halo Systems	540D	FDA UDI	Class II	Unknown
Cold Rush	B-232000011	FDA UDI	Class II	Active
Symbionic Leg	SMBE3253	FDA UDI	Class II	Unknown
Halo Systems	515400T	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3263	FDA UDI	Class II	Unknown
Halo Systems	JT-215	FDA UDI	Class II	Unknown
Dvt	MDSDVT51000	FDA UDI	Class II	Unknown
Halo Systems	540C	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE8273	FDA UDI	Class II	Unknown
Rheo Knee	RKN130003	FDA UDI	Class I	Active
Cold Rush	B-232000019	FDA UDI	Class II	Active
Symbionic Leg	SMBE7293	FDA UDI	Class II	Unknown
Halo Systems	516V2S	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.