Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
FDA Recall Z-0141-2018 · Posted None
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-09-19
Date Terminated2021-06-21
Product Quantity537 devices
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.
Firm Action
The recalling firm issued a letter dated 9/19/2017 via email to their customers.
Root Cause
Labeling design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.