Z-0165-2016 Class II Terminated
FDA device recall Z-0165-2016 was initiated by Encore Medical, Lp on Sep 16, 2015 and is designated Class II. Reason for recall: The labeling is missing the size/diameter information. The recall status is terminated (terminated Jan 4, 2016). Affected quantity: 209 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 4, 2015
- Initiation Date
- Sep 16, 2015
- Termination Date
- Jan 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209 units
Product description
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Reason for recall
The labeling is missing the size/diameter information.
Distribution pattern
US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Code information
471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0165-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026