Recall Z-2034-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2014-05-23, terminated 2015-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.. Reason: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-23
- Terminated
- 2015-03-06
- Firm location
- Warsaw, IN, United States
Product description
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Reason for recall
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Data sourced from openFDA. This site is unofficial and independent of the FDA.