Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns
Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.
The agency’s classification
FDA (Devices): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor, a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The recall covers devices released since 2004, including specific part numbers listed in the agency's structured data. The devices are provided non-sterile and must be sterilized prior to use in surgery.
The recall was initiated after Greatbatch identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved when the device is subjected to the steam sterilization cycles and associated dry times specified in the current Instructions For Use (IFU). The affected quantity is 7,245 devices worldwide, including 2,482 in the United States. Distribution includes the US and multiple international markets.
Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. Healthcare facilities and users should follow the instructions provided by Greatbatch Medical for the Field Corrective Action.
The recalled product
- Product
- Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, 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…
- Manufacturer
- Greatbatch Medical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
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