Manufacturers

Exactech, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 3 건

Exactech
  • 모델명 / 제조번호(시리얼번호)
    Tibial Augment block Trial, Catalog # 205-60-05, Lot #''s 4786-001 and 6509-001 Tibial Augment Block Trial, Catalog # 205-60-08 Lot #''s 4786-002 and 6509-002 Tibial Tray Trial, Catalog # 201-70-81, Lot #''s 4580-002, 6449-002 & 09861014 Trapezoid Tray Trial, Catalog # 205-70-81, Lot #''s 4603-002 & 6449-013
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.
  • 제품 설명
    Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.
Device Recall Exachtech
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 209-04-71, Lot # 10315011, Catalog # 209-04-72, Lot # 10315012; Catalog # 209-04-73, Lot # 10315013; Catalog # 209-04-74, Lot # 10315014 and Catalog # 209-04-75, Lot # 10315015.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was distributed directly to four distributors in OH, ME, HI and NY.
  • 제품 설명
    Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) || Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.
Device Recall ACUDRIVER
  • 모델명 / 제조번호(시리얼번호)
    Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
  • 제품 설명
    Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14

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Exactech, Inc.
  • 제조사 주소
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • 제조사 모회사 (2017)
    Exactech Inc
  • Source
    USFDA
Exactech, Inc.
Exactech, Inc.