Is this your brand? Sign in to claim ownership.

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 3 of 6

Device	Model / Reference	Registries	Class	Status
Halo Systems	505300C	FDA UDI	Class II	Unknown
Cold Rush	B-232000012	FDA UDI	Class II	Active
Symbionic Leg	SMBU7263	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100016	FDA UDI	Class II	Active
Halo Systems	515500D	FDA UDI	Class II	Unknown
Power Knee	PKN123007	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU1253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE2283	FDA UDI	Class II	Unknown
Rheo Knee	RKN13240	FDA UDI	Class I	Active
Dvt	DVT55001	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU8283	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU3253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU8293	FDA UDI	Class II	Unknown
Halo Systems	505501C	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU8303	FDA UDI	Class II	Unknown
Halo Systems	522CS	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU6263	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4283	FDA UDI	Class II	Unknown
Power Knee	PKA10001	FDA UDI	Class I	Active
Rheo Knee	RKN13200	FDA UDI	Class II	Unknown
Halo Systems	505300D	FDA UDI	Class II	Unknown
Rheo Knee	PRX00421	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4233	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4303	FDA UDI	Class II	Unknown
Halo Systems	516DS	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3303	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE6303	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5233	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100019	FDA UDI	Class II	Active
Cold Rush Compact	B-232100011	FDA UDI	Class II	Active
Cold Rush	B-232002402	FDA UDI	Class II	Active
Rheo Knee	RKN130203	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE8253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE7263	FDA UDI	Class II	Unknown
Power Knee	PK23100	FDA UDI	Class II	Unknown
Rheo Knee	RKN130002	FDA UDI	Class I	Active
Halo Systems	505500V2	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU7283	FDA UDI	Class II	Unknown
Halo Systems	505400C	FDA UDI	Class II	Unknown
Rheo Knee	RKN13140	EUDAMEDFDA UDI	Class I	Active
Power Knee	PK220007	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE1223	FDA UDI	Class II	Unknown
Rheo Knee	RKNLPCWB1	FDA UDI	Class I	Unknown
Symbionic Leg	SMBE7273	FDA UDI	Class II	Unknown
Power Knee	PK22100	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5283	FDA UDI	Class II	Unknown
Rheo Knee	RKNXC0005	EUDAMEDFDA UDI	Class I	Active
Symbionic Leg	SMBU5243	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE4283	FDA UDI	Class II	Unknown
Cold Rush	B-232002206	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.