Reported Dec 7, 2016 · Terminated
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04…
Greatbatch Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greatbatch Medical · 2300 Berkshire Ln N · Plymouth, MN · 55441-4575
Is this the product you have?
- Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1
T17238MMP3100CHA04T9954MMP3100CHA04T9955MMP3100CHA04T8468MMP3100CHA04T11506MMP3100CHA13T10281MMP3100CHA04T8044
~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl08617650255000110T8143803-t1-103Tl4384EK-00200690T1666tXEB227242T9316MIMP3100CHA04Tl3642500325T10753
- 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
- Lot codes and dates
- Lot Number& 3037420001 3037430001 & 3037440001 3037450001 &
366 of 366 codes
30491348972495656250009525302832543053256197625645182565790266167327427202742725274272627504452750447278930827943602799474279947528169922828788283295228426582853782292715229707622970798301693930189913018992301899330293523058553308781331387633148504316647431729183187998318800432522243270048327530657800012233370001223367000122421900012259200001225921000122716500012299480001229949000123158800012315890001231590000123159100012315920001232218000123625200012363250001
&303746000138522844655946847449360750299852068456566357335860035968210270181770183871136771204800017124590001712460000171246100017132510001714433000171443400017144350001714872000171494300017153590001
No Lot Code71536000017177130001718844000172123900017234560001723457000172424200017242430001724501000172450200017245030001725538000172553900017255400001725541000172630300017263040001726707000172679500017267960001726797000172679800017267990001743422773568799699841060847862877907892823968916991034CIDO00DIAP00MCT705-05A178MCT705-07D851MCT705-07D851MCT705-09B220MCT705-10F633MS1063
OF-002-29515-0001OF-002-32530-0001OF-002-41119-0001OF-002-42944-0001OF-002-44825-0001OF-002-44826-0001OF-002-45448-0001OF-002-45665-0001OF-002-46173-0001OF-002-49050-0001OF-002-50500-0001OF-002-50501-0001OF-002-53569-0001OF-002-58260-0001OF-002-61715-0001OF-002-72372-0001OF-002-72373-0001OF-002-72420-0001OF-002-75542-0001OF-003-01045-0001
- Lot Number
- Amount recalled
- 4478 (2906 US, 1572 OUS)
Where it was sold
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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