Z-0135-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- September 19, 2017
- Termination Date
- June 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 733 devices
Product Description
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Reason for Recall
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Distribution Pattern
Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
Code Information
All lot numbers