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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 4 of 6

Device	Model / Reference	Registries	Class	Status
Cold Rush	B-232002600	FDA UDI	Class II	Active
Power Knee	PKA01001T	FDA UDI	Class I	Active
Halo Systems	531C	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU6293	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE1243	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3293	FDA UDI	Class II	Unknown
Halo Systems	515400D	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4293	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE3243	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU8263	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE7303	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100012	FDA UDI	Class II	Active
Power Knee	PK218001	FDA UDI	Class II	Unknown
Cold Rush	B-232000013	FDA UDI	Class II	Active
Halo Systems	505500T	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU7253	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU2243	FDA UDI	Class II	Unknown
Dvt	DVT55002	FDA UDI	Class II	Unknown
Dvt	DVT62203	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU4263	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU7293	FDA UDI	Class II	Unknown
Rheo Knee	RKNXC0002	EUDAMEDFDA UDI	Class I	Active
Symbionic Leg	SMBE8263	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU6283	FDA UDI	Class II	Unknown
Symbionic Leg	SBL12112	FDA UDI	Class II	Unknown
Cold Rush Compact	B-232100013	FDA UDI	Class II	Active
Cold Rush	B-232002500	FDA UDI	Class II	Active
Symbionic Leg	SMBU5223	FDA UDI	Class II	Unknown
Rheo Knee	RKN12100	FDA UDI	Class I	Active
Symbionic Leg	SMBE4233	FDA UDI	Class II	Unknown
Dvt	MDSDVT62204	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE6283	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU6253	FDA UDI	Class II	Unknown
Symbionic Leg	SBL13211	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU5303	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE2233	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE2263	FDA UDI	Class II	Unknown
Power Knee	PKN120037	FDA UDI	Class II	Unknown
Halo Systems	515400V2	FDA UDI	Class II	Unknown
Power Knee	PK230010	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE8303	FDA UDI	Class II	Unknown
Cold Rush	B-232000025	FDA UDI	Class II	Active
Halo Systems	505400V2	FDA UDI	Class II	Unknown
Rheo Knee	RKN13210	FDA UDI	Class I	Active
Symbionic Leg	SMBE2243	FDA UDI	Class II	Unknown
Symbionic Leg	SMBE5223	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU2273	FDA UDI	Class II	Unknown
Dvt	DVT51000	FDA UDI	Class II	Unknown
Symbionic Leg	SMBU3263	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.