Device Recall Restoration

  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.
  • 제품 설명
    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. || 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; || 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; || 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; || 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; || 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; || 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; || 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; || 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; || 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; || 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; || 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; || 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; || 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; || 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; || 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; || 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; || 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; || 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; || 6260-3-214 KINKED T3 DIST STM 14MMX265MM; || 6260-3-215 KINKED T3 DIST STM 15MMX265MM; || 6260-3-216 KINKED T3 DIST STM 16MMX265MM; || 6260-3-217 KINKED T3 DIST STM 17MMX265MM; || 6260-3-218 KINKED T3 DIST STM 18MMX265MM; || 6260-3-219 KINKED T3 DIST STM 19MMX265MM; || 6260-3-220 KINKED T3 DIST STM 20MMX265MM; || 6260-3-222 KINKED T3 DIST STM 22MMX265MM; || 6260-3-224 KINKED T3 DIST STM 24MMX265MM; || 6260-3-314 KINKED T3 DIST STM 14MMX305MM; || 6260-3-315 KINKED T3 DIST STM 15MMX305MM; || 6260-3-316 KINKED T3 DIST STM 16MMX305MM; || 6260-3-317 KINKED T3 DIST STM 17MMX305MM; || 6260-3-318 KINKED T3 DIST STM 18MMX305MM; || 6260-3-319 KINKED T3 DIST STM 19MMX305MM; || 6260-3-320 KINKED T3 DIST STM 20MMX305MM; || 6260-3-322 KINKED T3 DIST STM 22MMX305MM; || 6260-3-324 KINKED T3 DIST STM 24MMX305MM; || LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; || 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; || LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; || LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Howmedica Osteonics, 300 Commerce Ct, Mahwah NJ 07430-2104
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 37 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64) All Lots K093644
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution.
  • 제품 설명
    Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France || The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No: 1235-2-8XX (XX+48, 50, 52, 54, 56, 58, 60, 63, 64)  All Lots K0272020
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution.
  • 제품 설명
    Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France || The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 6276-7-017 (17mm), Lot Code CAXHA68D; Catalog No. 6276-7-014, (14mm) Lot Code CAXHB18A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Class II Recall - Nationwide Distribution
  • 제품 설명
    Restoration Modular Conical Distal Stem; || Sterile, Titanium Alloy. One unit per package. || Stryker Ireland || Carrigtwohill County Cork, Ireland. || Authorized Representative in Europe: Stryker France, Cedex France. || This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
  • Manufacturer
  • 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
  • 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
  • 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
  • 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
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