Device recall: Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04…
Class I FDA enforcement event 75043. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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 Impactor’s Instructions for Use (IFU).
Class I, in the words of FDA
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
Greatbatch Medical started this device recall on 2 Aug 2016. The firm address in the FDA record is in Plymouth, MN. FDA put the recall in Class I. FDA event 75043 has 1 product record. The first FDA enforcement report date is 7 Dec 2016. The record gives the status Terminated, with the termination date 27 Jul 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Greatbatch Medical, Plymouth, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0367-2017 | 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… | 4478 (2906 US, 1572 OUS) | Class I | Terminated | 7 Dec 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class I
- 3%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 14
Other events of the firm
Official channels
- FDA enforcement report Z-0367-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 75043. https://recallregister.com/fda/i/75043/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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…
- What quantity of product is in FDA event 75043?
- The FDA record gives this quantity:
4478 (2906 US, 1572 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 3% of the 1,232 device events that started in 2016 are in Class I.