BEUDAMED
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    SHARP DISPOSAL CONTAINERS WALL SAFE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123007·K-WIRE - SINGLE TROCAR 1.6mm DIA x 150mm

    PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    APPLIED MEDICAL·Product code FZP·January 18, 2013

    PROVISC (IN DUOVISC)

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·December 10, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2014

    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