FDA recall Z-0127-2018

Product

Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, 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

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.

Key facts

Status

Terminated

Initiation date

2017-09-19

Report date

2017-11-29

Termination date

2021-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2018