BEUDAMED
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    SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776108380·Ejector Rongeur, Ceramic Coat,

    faceLITE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN DEPUY ASR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 29, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 11, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVY·July 3, 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