BEUDAMED
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    AEROSOL ONE, NEBULIZER PUMP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MEDICOM SELF-SEALING STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    12/14 ARTICUL 40MM M SPEC+1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.-8010379·Product code LPH·June 12, 2014

    MBT CEM TIBIAL TRAY SZ5

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·October 11, 2010

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 13, 2012

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021