Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure
Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.
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: "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…"
Plain-English summary
Greatbatch Medical is recalling Standard Offset Cup Impactors equipped with a POM-C handle grip. The recall was initiated after the company discovered on December 17, 2015, that these specific instruments failed sterility testing when housed in a dedicated instrument case and sterilized using the parameters identified in the product's Instructions for Use (IFU).
The affected products are handheld, reusable surgical instruments used to position and seat acetabular cups during hip joint replacement surgery. The recall covers 4,478 units, with 2,906 distributed in the United States and 1,572 distributed internationally. Distribution in the US included California, Indiana, Kansas, New Jersey, North Carolina, Tennessee, Texas, and Utah, while international distribution included multiple countries in Europe, Asia, and Oceania.
No specific instructions for consumer action are provided in the source text, as these are professional medical devices. Healthcare facilities and users should verify their inventory against the provided lot numbers and contact Greatbatch Medical for further guidance on the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Greatbatch Medical
Distribution
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