Facility

Ossur Iceland ehf.

7 recall(s) on record — most severe on record: Class II.

Key facts

7recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003764610
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	GRJOTHALS 5 REYKJAVIK, IS 110
Registration status	Active · expires 2026
Parent company	OSSUR Americas (owner-operator 9026971)
Brand names	Miami TLSO 456; Miami TLSO 464

Activity by year

Recalls (7)

Devices registered here (1)

Orthosis, Thoracic
Product code IPT (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3490

Recalls & enforcement

Class IIOngoing2022-08-29
Battery may dislodge from the Power Knee
Class IITerminated2022-05-30
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.
Class IITerminated2021-11-09
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Class IITerminated2021-06-01
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.
Class IITerminated2018-06-21
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.
Class IITerminated2012-10-15
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
Class IITerminated2012-02-12
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Ossur Iceland ehf. (FEI 3003764610) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003764610-ossur-iceland-ehf/

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