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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 5 of 6

Device	Model / Reference	Registries	Class	Status
Halo Systems	517DS	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3273	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5263	FDA UDI	Class II	Unknown
Power Knee	PKA10002	FDA UDI	Class I	Active
Symbionic Leg	SMBE6253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU7303	FDA UDI	Class II	Unknown
Halo Systems	515300C	FDA UDI	Class II	Unknown
Cold Rush	B-232002000	FDA UDI	Class II	Active
Symbionic Leg	SMBU3283	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU2223	FDA UDI	Class II	Unknown
Halo Systems	505500C	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4273	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE2253	FDA UDI	Class II	Unknown
Halo Systems	515C	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU1223	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5273	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU3303	FDA UDI	Class II	Unknown
Symbionic Leg	SBL13111	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100018	FDA UDI	Class II	Active
Symbionic Leg	SMBE6263	FDA UDI	Class II	Unknown
Dvt	MDSDVT62201	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100015	FDA UDI	Class II	Active
Symbionic Leg	SMBE1233	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5293	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU2253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE7283	FDA UDI	Class II	Unknown
Halo Systems	515300D	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU3233	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU1243	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU2263	FDA UDI	Class II	Unknown
Cold Rush	B-232000018	FDA UDI	Class II	Active
Symbionic Leg	SMBE6293	FDA UDI	Class II	Unknown
Dvt	DVT-SAMPLE	FDA UDI	Class II	Unknown
Halo Systems	522C	FDA UDI	Class II	Unknown
Cold Rush	B-232000010	FDA UDI	Class II	Active
Cold Rush	B-232000015	FDA UDI	Class II	Active
Halo Systems	515300T	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3283	FDA UDI	Class II	Unknown
Halo Systems	516CS	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5303	FDA UDI	Class II	Unknown
Halo Systems	505300T	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE6273	FDA UDI	Class II	Unknown
Dvt	DVT67119	FDA UDI	Class II	Unknown
Halo Systems	515500T	FDA UDI	Class II	Unknown
Cold Rush	B-232002202	FDA UDI	Class II	Active
Power Knee	PK218000	FDA UDI	Class II	Unknown
Rheo Knee	RKN13100	FDA UDI	Class I	Active
Symbionic Leg	SMBU3223	FDA UDI	Class II	Unknown
Halo Systems	540V2	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.