Reported Mar 12, 2014 · Terminated
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600,…
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 · Minneapolis, MN · 55441-4575
Is this the product you have?
- Greatbatch Medical, Offset Cup Impactor
- Part NumbersP9485, 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 3-28-2014The following
- Part Numbers are also affected
P10270P6427P6464P6501P7611P7640P7794P7927P8233P8590T10006T10261T10606T10835T11095T11506T11622T12081T12083T12124T12125T13435T13527T14174T15262T15515T16418T16551T16552T16553T17272T5709T6744T7751T9195
- Lot codes and dates
- all lots
- Amount recalled
- 4870 worldwide (2482 US), EXPANDED: 7245 devices
Where it was sold
Why it was recalled
Stop using this product now
Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
Using this product could cause serious injury, illness or death — stop using it now.
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