Medical Device Safety and Recalls: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization

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. Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received by taking our Customer Service Survey.

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)