Devices

Device Recall Restoration Modular Hip System

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 6276-1-019; REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular Hip System; Proximal Cone Body; || 19 mm +0 mm (STD); || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

제조사

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall Restoration Modular Hip System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 627601-027; REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069602 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069603 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069602 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069603 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081903 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29448101 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29448101 30-Mar-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular Hip System; Proximal Cone Body; || 27 mm +0 mm (STD); || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Restoration Modular Hip System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 6276-1-127;  REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28932002 23-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28932002 23-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28932002 23-Feb-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular Hip System; Proximal Cone Body; || 27 mm +10 mm; || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Restoration Modular Hip System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 6276-7-014; REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826A 27-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826F 29-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10E 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10E 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10E 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10A 19-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10A 19-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10C 20-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10C 20-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10C 20-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10D 05-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10D 05-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10D 05-Mar-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular hip System, Conical Distal Stem, 14 mm x 155 mm; Straight, Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty, as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Restoration Modular Hip System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 6276-7-015; REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910G 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910C 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910C 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910D 27-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909C 09-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909D 24-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909G 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910F 24-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910F 24-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827C 13-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular Hip System, Conical Distal Stem, 15 mm x 155 mm; Straight, Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Restoration Modular Hip System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 6276-1-021; REST MOD PROX CONE BODY 21mm +0mm (STD) 28733303 22-Jan-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733303 22-Jan-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847903 11-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847903 11-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29476201 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29476201 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29492001 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29285601 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29421001 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29421001 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29285601 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular Hip System; Proximal Cone Body; || 21 mm +0 mm (STD); || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
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