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 6 of 6

Device	Model / Reference	Registries	Class	Status
Halo Systems	515300V2	FDA UDI	Class II	Unknown
Halo Systems	JT-115	FDA UDI	Class II	Unknown
Dvtcare Ca5	K130174	FDA 510(k)	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.