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The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Greatbatch Medical Standard Offset Cup Impactors with POM-C Handle. The Standard Offset Cup Impactors are reusable handheld devices used during hip joint replacement surgeries to implant cups in the hip socket (acetabulum).
The device is provided as non-sterile and must be sterilized prior to use in surgery. During hip replacement surgery, the ball (femoral head) is removed and replaced with a prosthetic ball, and the acetabulum is removed and replaced with a prosthetic cup. Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case. Learn more...
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