BEUDAMED
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    Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS) Catalog #DUP87810. f. DERMA SCIENCES, INC Shur-Conform Oil Emulsion non-adhering DRESSING, OIL EMULSION 3"X3"23251-210 DERSCI Catalog #DKC77041

    FDA Enforcement
    Class III ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    InSound Medical, Inc, Lyric in-canal hearing aid.

    FDA Recall
    Terminated ·InSound Medical, Inc.·Product code ESD·January 19, 2010

    ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·December 7, 2016

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer, Winterthur, Switzerland; REF 01.00214.160. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z, Zimmer, Winterthur, Switzerland; REF 01.00214.166. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 48/42, code H, Zimmer, Winterthur, Switzerland; REF 01.00214.148. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 52/46, code L, Zimmer, Winterthur, Switzerland; REF 01.00214.152. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 46/40, code F, Zimmer, Winterthur, Switzerland; REF 01.00214.146. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 64/58, code X, Zimmer, Winterthur, Switzerland; REF 01.00214.164. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 56/50, code P, Zimmer, Winterthur, Switzerland; REF 01.00214.156. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N, Zimmer, Winterthur, Switzerland; REF 01.00214.154. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D, Zimmer, Winterthur, Switzerland; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 62/56, code V, Zimmer, Winterthur, Switzerland; REF 01.00214.162. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018

    Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tapered necks.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LPH·August 3, 2009

    DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 7, 2009

    Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION FEMORAL VALGUS ALIGNMENT GUIDE, REF 00-5901-067-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MBH·March 14, 2011

    Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION QUICK-CONNECT HANDLE, REF 00-5901-034-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MBH·March 14, 2011