Z-0953-2013 Class II Terminated
FDA device recall Z-0953-2013 was initiated by Exactech, Inc. on Feb 1, 2013 and is designated Class II. Reason for recall: A dimensional mismatch was identified which can potentially allow for interference between devices. The recall status is terminated (terminated Sep 22, 2014). Affected quantity: 123 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2013
- Initiation Date
- Feb 1, 2013
- Termination Date
- Sep 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 devices
Product Description
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Reason for Recall
A dimensional mismatch was identified which can potentially allow for interference between devices.
Distribution Pattern
Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
Code Information
Catalog # 02-012-42-3508 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-0953-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026