Medical Device Safety and Recalls: Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks - Higher than Expected Levels of Manufacturing Residues

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

Title: Medical Device Safety and Recalls: Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks - Higher than Expected Levels of Manufacturing Residues

A recall has been issued for Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks.  The company found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices.  These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death.  Use of these products may require the need for a revision surgery to replace the affected implant.  The company has not received any complaints related to this issue for any of the lots in distribution.

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