Devices

Device Recall Trident

  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers: 502-11-42A, 42mm;502-11-44b, 44mm; 502-11-46C, 46mm; 502-11-48D, 48mm; 502-11-50D, 50mm; 502-11-52E, 52mm; 502-11-54E, 54mm; 502-11-56F, 56mm; 502-11-58F, 58mm; 502-11-60G, 60mm; 502-11-62G, 62mm; 502-11-64H, 64mm; 502-11-66H, 66mm; 502-11-68I, 68mm; 502-11-70I, 70mm; 502-11-72J. 72mm; 502-11-74J, 74mm.   All lot codes with expiration dates between 1/2005 and 12/2012.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution.
  • 제품 설명
    Trident Hemispherical HA Cluster, 42 mm - 74mm || Arc Deposited; || Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

제조사

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall Trident Universal Impactor/Positioner
  • 모델명 / 제조번호(시리얼번호)
    Catalog No: 2101-0200, Lot Nos. SMM7A00, SMM7A00L, SMM7A02, SMM7A02A, SMM7A02E, SMM7A02EE, SMM7A01T, SMM7A01TT, SMM7A01TD, SMM7A01TDD, SMM7C02H, SMM7C02, SMM7C01, SMM7C01T, SMM7C01TT, SMM7C01W, SMM7E03, SMM7E03A, SMM7E00, SMM7A00E, SMM7E02, SMM7E02A, SMM7E01, SMM7E01A, SMM7K00. SMM7K01, SMM7K01A, SMM7K03, SMM7K03L, SMM7K02, SMM7K02T, SMM7K03X, SMM7K03Y, SMM7C02J, SMM7L00H, SMM7L00J, SMM7L00K, SMM7L00, SMM7C01TW, SMM7M01, SMM7A02T, SMM7M00, SMM7M00A, SMM7M02H, SMM7M02, SMM7E02M, SMM7E01JK, SMM7K03J, SMM7K00A, SMM6N04, SMM7N01J, SMM7N01, SMM7M06, SMM7M09, SMM7N03, SMM7N03A, SMM7M06A, SMM7M09, SMM7N00, SMM7M05, SMM7M08A, SMM7M10, SMM7N00A, SMM7N02L, SMM7M05J, SMM7M08, SMM7N02, SMM7N04, SMM7N04J, SMM8C00, SMM7M01R, SMM7M01RW, SMM7M01W, SMM7M07, SMM7M07J, SMM6C00, SMM7M03, SMM7M03A, SMM7M03D, SMM7M03E, SMM7M03L, SMM7M04, SMM7M04L, SMM7M03K, SMM8C00J, SMM8L05, SMM8L05A, SMM8L02X, SMM8L04, SMM6N00, SMM6N01, SMM6N01A, SMM6N02, SMM6N03, SMM6N04A, SMM8L07T, SMM8L08, SMM8M00K, SMM8M00L, SMM8M01, SMM8M01E, SMM8M01EE, SMM8N02, SMM8N02A, SMM8M01A, SMM8N00, SMM8N00A, SMM8N00D, SMM8N01, SMM8N01A, SMM8N01T, SMM8S00, SMM8S00T, SMM8S00TT, SMM8S01, SMM8S01A, SMM8S01D, SMM8T00, SMM8N02T, SMM8S02, SMM8V00, SMM8V00A, SMM8V00E, SMM8T00A, SMM8V01, SMM8V01A, SMM8W02, SMM8W03A, SMM8V02, SMM8W01, SMM8W01A, SMM8W02X, SMM8W03M, SMM8W03P, SMM8W04, SMM8W04A, SMM8W05, SMM8W05A, SMM8W03D, SMM8W03, SMM8W05D, SMM8W00A, SMM8W00E, SMM8W00J, SMM8W00K, SMM8W00, SMM8V02J, SMM8W00D, SMM8V07, SMM8W06H, SMM8W05H, SMM8W00H, SMM8W07, SMM8W07K, SMM8W07L, SMM8W08, SMM8W08E, SMM8W07A, SAMPLE25, SMM8W08EE, SMM9A00, SMM9A00R, SMM9A00T, SMM9A01, SMM9A01E, SMM9A01EL, SMM9A02, SMM9A02E, SMM9A03, SMM9A03K, SMM9A03L, SMM9A03P, SMM8L01, SMM8L03, SMM8L07, SMM8L00T, SMM8L07, SMM9A05, SMM9A06, SMM9A06E, SMM9A07, SMM9A08, SMM9A12, SMM9A12J, SMM9A12T, SMM9A09, SMM9A09K, SMM9A09L, SMM9A10, SMM9A11, SMM9A11D, SMM9A07L, SMM9E01, SMM9E02, SMM9E02A, SMM9E03, SMM9E00, SMM9C00A, SMM9C00D, SMM9C00, SMM9C00J, SMM9C00K, SMM9E05A, SMM9E04, SMM9E04A, SMM9E04D, SMM9E04E, SMM9E05, SMM9E04T, SMM9E04TT, SMM9E06, SMM9E06A, SMM9E06D, SMM9A03HD, SMM9A12X, SMM9H01, SMM9H01A, SMM9H01T, SMM8V01D, SMM8V05, SMM8V06, SMM8V04, SMM8V03, SMM9H00E, SMM9H00EE, SMM9H00K, SMM9H00L, SMM9H00V, SMM9K00, SMM9K01, SMM9K01AT, SMM9K01T, SMM8K01TT, SMM9K02A, SMM9K03, SMM9K02, SMM9K04, SMM9L00, SMM9L01, SMM9L02, SMM9L02A, SMM9L02E, SMM9L02M, SMM9L03, SMM9L03A, SMM9L03D, SMM9L03E, SMM9L04, SMM9L04D, SMM9L04E, SMM9L05, SMM9L04A, SMM9L07, SMM9L07A, SMM9L09, SMM9L09A, SMM9L09D, SMM9V00, SMM9V02A, SMM9V02D, SMM9V05, SMM9V07, SMM9V08A, SMM9A04, SMM9L09E, SMM9L10, SMM9L08, SMM9L08A, SMM9A09P, SMM9K01L, SMM9L06, SMM9M01L, SMM9M01, SMM9M01A, SMM9M03, SMM9M03A, SMMM03D, SMM9M03E, SMM0M02, SMM9M02A, SMM9M02L, SMM9M00, SMM9L10A, SMM9N02M, SMM9N02, SMM9N00, SMM9N00X, SMM9N00Y, SMM9N02K, SMM9N02J, SMM9N01, SMM9N01A, SMM9N01J, SMM9N05A, SMM09N05, SMM9N05D, SMM9N07J, SMM9H01K, SMM9N07JK, SMM9N07N, SMM9T01, SMMN9T01, SMM9T00, SMM0T00A, SMM9T02, SMM8V07A, SMM7E01T, SMM7K01AA, SMM0T00K, SMM9T00J, SMM9T03, SMM9T03A, SMM9T03D, SMM8W01AA, SMM9T03N, SMM9T03L, SMM9T03M, SMM8V01T, SMM8V07T, SMM8W00T, SMM8V03T, SMM8V05T, SMM8V07TT, SMM9V01, SMM9V01A, SMM9V01T, SMM9V01D, SMM9V01J, SMM9V01X, SMM9V00A, SMM9V08, SMM9V08AA, SMM09V06, SMM9V09J, SMM9V04, SMM9V09, SMM9V09A, SMM9V09K, SMM9V03, SMM9V02E, SMM9V02H, SMM9V02K, SMM9V09E, SMM9V09L, SMM9V09LE, SMM9V09LL, SMM9V00HJ, SMM9V00JH, SMM9V00H, SMM9N03, SMM9N04, SMM9N06, SMM9N06A, SMM9N07, SMM09N08, SMM9N08E, SMM9N07A, SMM9N07AA , SMM9N08A, SMM9N08D, SMM9N06T, SMM9N06TA and SMM9N07M
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US and Internationally
  • 제품 설명
    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430, USA, A Subsidiary of Stryker Corp.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
  • 모델명 / 제조번호(시리얼번호)
    Identifier EUS-22-1-N UPN ES34591 M171226171
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution to one distributor in MI.
  • 제품 설명
    Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
  • Manufacturer
    Micro-Tech (Nanjing) Co., Ltd.
Device Recall Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
  • 모델명 / 제조번호(시리얼번호)
    Identifier EUS-22-0-N UPN ES34601 M171226172
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution to one distributor in MI.
  • 제품 설명
    Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
  • Manufacturer
    Micro-Tech (Nanjing) Co., Ltd.
Device Recall Trident
  • 모델명 / 제조번호(시리얼번호)
    Part Number T18116, 30 per case, Lot Number: 579811104;  Part Number T61500, 14 per case, Lot Numbers: 572171004, 585301204
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
  • 제품 설명
    Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M). Manufactured for GEO Logistics, Copenhagen, Denmark, Made in Mexico
  • Manufacturer
    MMS Sales Corp
Device Recall Trident PSL Acetabular Shell;
  • 모델명 / 제조번호(시리얼번호)
    Catalog number/ lot code: 540-11-56F 36906101 540-11-58G 37048901 540-11-58G 37122001 542-11-46D 34977701 542-11-46D 35105901 542-11-46D 35382701 542-11-46D 35483101 542-11-46D 35525001 542-11-46D 35584201 542-11-46D 37497001 542-11-46D 37830601 542-11-46D 37884701 542-11-46D 38034101 542-11-46D 38124501 542-11-48D 35028401 542-11-48D 35332701 542-11-48D 35406002 542-11-48D 35406003 542-11-48D 35687701 542-11-48D 35726401 542-11-48D 35834801 542-11-48D 37790101 542-11-48D 37891501 542-11-48D 38025001 542-11-48D 38025002 542-11-48D 38160501 542-11-50E 35032701 542-11-50E 35207301 542-11-50E 35385903 542-11-50E 35428901 542-11-50E 35428903 542-11-50E 35481501 542-11-50E 35481502 542-11-50E 35481502 542-11-50E 35515802 542-11-50E 35827902 542-11-50E 36966303 542-11-50E 37344301 542-11-50E 37515302 542-11-50E 37695201 542-11-50E 37888201 542-11-50E 37920201 542-11-50E 38245801 542-11-50E 38274303 542-11-52E 32886803 542-11-52E 35018402 542-11-52E 35018403 542-11-52E 35018404 542-11-52E 35085001 542-11-52E 35199201 542-11-52E 35199202 542-11-52E 35199204 542-11-52E 35325401 542-11-52E 35325403 542-11-52E 35373402 542-11-52E 35373403 542-11-52E 35419904 542-11-52E 35726002 542-11-52E 35866302 542-11-52E 35866304 542-11-52E 37057001 542-11-52E 37096702 542-11-52E 37368002 542-11-52E 37886202 542-11-52E 37886204 542-11-52E 37886206 542-11-52E 37925602 542-11-52E 37995901 542-11-52E 37995902 542-11-54F 35091602 542-11-54F 35186502 542-11-54F 35732703 542-11-54F 35868801 542-11-54F 35965101 542-11-54F 37443401 542-11-54F 37443403 542-11-54F 37789201 542-11-54F 37916502 542-11-54F 38095601 542-11-54F 38223203 542-11-56F 35081001 542-11-56F 35225301 542-11-56F 35225302 542-11-56F 35225303 542-11-56F 35290801 542-11-56F 35335101 542-11-56F 35524501 542-11-56F 35535102 542-11-56F 35831001 542-11-56F 36330001 542-11-56F 36542101 542-11-56F 36542102 542-11-56F 36768001 542-11-56F 36907201 542-11-56F 37050902 542-11-56F 37461501 542-11-56F 37743301 542-11-56F 38099001 542-11-58G 35638002 542-11-58G 35959701 542-11-58G 35959702 542-11-58G 36052801 542-11-58G 36137301 542-11-58G 36195501 542-11-58G 36195502 542-11-58G 36332802 542-11-58G 36372301 542-11-58G 36412601 542-11-58G 36430601 542-11-58G 36489601 542-11-58G 36489602 542-11-58G 36553001 542-11-58G 36583801 542-11-58G 36633201 542-11-58G 36758901 542-11-58G 36758902 542-11-58G 36898201 542-11-58G 37049101 542-11-58G 37049102 542-11-58G 37049103 542-11-58G 37122401 542-11-58G 37122402 542-11-58G 37122403 542-11-58G 37173201 542-11-58G 37242901 542-11-58G 37242902 542-11-58G 37279901 542-11-58G 37332301 542-11-58G 37500801 542-11-58G 37500801 542-11-58G 37500803 542-11-58G 37826804 542-11-60G 34806101 542-11-60G 34907101 542-11-60G 35666901 542-11-60G 35946101 542-11-60G 36002201 542-11-60G 36406701 542-11-60G 36435401 542-11-60G 36765101 542-11-60G 37119701 542-11-60G 37119702 542-11-60G 37273901 542-11-60G 37402101 542-11-62G 37358901 542-11-62H 34930801 542-11-62H 35272101 542-11-62H 35508901 542-11-62H 36270401 542-11-62H 36842101 542-11-64H 36406301 542-11-64H 37082601 542-11-64H 37358801 542-11-64H 37859901
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide -USA, Romania, Chile and Brazil.
  • 제품 설명
    Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., || 325 Corporate DriveMahway, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
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