The Recall Desk

FDA (Devices) recall action 66547

ConMed Corporation recalled 2 products on 2013-11-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-27
Critical
0
Units
—

Why these products were recalled

The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Devices)··2013-11-27

    ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Particulate Matter

    ConMed is recalling 147 Altrus Thermal Tissue Fusion handpieces because they were exposed to higher-than-acceptable particulate matter during manufacture.

    Product
    ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-27

    ConMed Altrus Thermal Tissue Fusion Handpieces Recalled for Particulate Matter

    ConMed is recalling 65 Altrus Thermal Tissue Fusion handpieces exposed to excessive particulate matter during manufacture, which could cause minor local infections.

    Product
    ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece…
    Category
    Distribution
    0 states