2 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117, T16427, T16604, T16611, T16661, T16829, T16934, T17062, T17203, T17238, T17321, T6318, T7821, T8042, T8043, T8044, T8087, T8088, T8093, T8095, T8177, T8184, T8277, T8310, T8333, T8468, T8487, T9109, T9196, T9205, T9316, T9348, T9360, T9556, T9557, T9747, T9894, T9954, T9955, T9999. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). EXPANDED 3-28-2014: The following Part Numbers are also affected: P10270, P6427, P6464, P6501, P7611, P7640, P7794, P7927, P8233, P8590, T10006, T10261, T10606, T10835, T11095, T11506, T11622, T12081, T12083, T12124, T12125, T13435, T13527, T14174, T15262, T15515, T16418, T16551, T16552, T16553, T17272, T5709, T6744, T7751, T9195.
FDA Enforcement
Class I
·Terminated·Greatbatch Medical·March 12, 2014
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1 7650 255000110 T8143 803-t 1-103 Tl4384 EK-00200690 T1666t XEB227242 T9316 MIMP3100CHA04 Tl3642 500325 T10753 ~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl0861 MMP3100CHA04 T16427 MMP3100CHA04 T9894 :-. MMP3100CHA04 T12861 MMP3100CHA\041 T8088 2002CUPI T1661 1 T16611 Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.
FDA Enforcement
Class I
·Terminated·Greatbatch Medical·December 7, 2016