FDA Device recall Z-0367-2017
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04…
- FDA Device
- Class I
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class I recall of Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04… by Greatbatch Medical, citing on December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case usin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0367-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-08-02 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Greatbatch Medical |
| Distribution | CA, IN, KS, NC, NJ, TN, TX, UT |
Product
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.
Reason
On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).
Identifiers
| code_info | Lot Number 30491 34897 2495656 2500095 2530283 2543053 2561976 2564518 2565790 2661673 2742720 2742725 274…Lot Number 30491 34897 2495656 2500095 2530283 2543053 2561976 2564518 2565790 2661673 2742720 2742725 2742726 2750445 2750447 2789308 2794360 2799474 2799475 2816992 2828788 2832952 2842658 2853782 2927152 2970762 2970798 3016939 3018991 3018992 3018993 3029352 3058553 3087813 3138763 3148504 3166474 3172918 3187998 3188004 3252224 3270048 3275306 5780001 2233370001 2233670001 2242190001 2259200001 2259210001 2271650001 2299480001 2299490001 2315880001 2315890001 2315900001 2315910001 2315920001 2322180001 2362520001 2363250001 2371900001 2371910001 2371920001 2371950001 2378420001 2459710001 2471740001 2487360001 2490460001 2491700001 2491710001 2504910001 2504930001 2504950001 2516110001 2518340001 2518350001 2518370001 2528690001 2553410001 2553440001 2553450001 2559210001 2566230001 2595380001 2627950001 2665630001 2724230001 2725870001 2725880001 2745160001 2766420001 2781250001 27820100 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0367-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.