Z-0138-2018 Class II Terminated
FDA device recall Z-0138-2018 was initiated by Exactech, Inc. on Sep 19, 2017 and is designated Class II. 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. The recall status is terminated (terminated Jun 21, 2021). Affected quantity: 527 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2017
- Initiation Date
- Sep 19, 2017
- Termination Date
- Jun 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 527 devices
Product Description
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0138-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026