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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The failure of sterility testing on a surgical instrument used in open joint replacement surgery presents a significant risk of infection, fitting the criteria for a High severity rating due to the risk of harm, even though specific injury reports are not detailed in the provided text.
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 MMP3100CHA0
- Manufacturer
- Greatbatch Medical
Distribution
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