Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491…
Medical device recall Z-0367-2017. Published in FDA’s Enforcement Report on Dec 7, 2016.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 7, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- 8 states named in where it went
- 4478 (2906 US, 1572 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
4478 (2906 US, 1572 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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 2782010001 3006450001 3007860001 3029980001 3037400001 3037470001 3038530001 3038560001 3038700001 3038720001 3038730001 3038740001 3038750001 3038760001 3038790001 3038800001 3038810001 3038820001 3038830001 3038840001 3038850001 3038860001 3039320001 3039330001 3046100001 3046200001 3060700001 3061130001 3061390001 3061930001 3062700001 3065930001 3066030001 3066060001 3068430001 3083790001 3086350001 3091750001 3092720001 3092730001 3093900001 4006680001 4007350001 4007560001 6342540001 6411410001 6411450001 7004290001 7008770001 7010540001 7011200001 7011240001 7014640001 7019390001 7022800001 7022810001 7023900001 7023900002 7032220001 7032230001 7033140001 7033830001 7036020001 7043510001 7046530001 7047580001 7054290001 7055180001 7064180001 7064340001 7067270001 7067280001 7068200001 7068300001 7068310001 7070520001 7072060001 7072070001 7072370001 7072370001 7072380001 7072610001 7075380001 7084500001 7085220001 7085620001 7085660001 7094580001 7094640001 7095080001 7095400001 7095410001 7097350001 7099830001 7100040001 7102740001 7102860001 7103040001 7103110001 7103350001…
FDA’s list runs to 4,922 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGDOM, AUSTRALIA, AUSTRIA, BELGIUM, SWITZERLAND, NORWAY, SWEDEN, and TAIWAN.
The states and territories these words name
- California
- Indiana
- Kansas
- North Carolina
- New Jersey
- Tennessee
- Texas
- Utah
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 2, 2016.
- FDA classified it on Nov 29, 2016.
- FDA’s Enforcement Report published it on Dec 7, 2016.
- FDA terminated it on Jul 27, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Greatbatch Medical, of Plymouth, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,922 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.