RegWardenFDA facility compliance records
Company

OSSUR Americas

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

Recalls by year

FDA actions on record by year2012: 2 recalls; 2018: 1 recalls; 2021: 2 recalls; 2022: 2 recalls2’12’13’14’15’16’171’18’19’202’212’22’23’24’25’26
  • Recalls (7)

Registered facilities (8)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “OSSUR Americas — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9026971-ossur-americas/

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