Z-2302-2012 Class II Terminated
FDA device recall Z-2302-2012 was initiated by Encore Medical, Lp on Aug 9, 2012 and is designated Class II. Reason for recall: The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be… The recall status is terminated (terminated Jan 25, 2013). Affected quantity: 7 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 5, 2012
- Initiation Date
- Aug 9, 2012
- Termination Date
- Jan 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product description
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
Reason for recall
The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
Distribution pattern
Worldwide Distribution including Venezuela.
Code information
Model Number 392-09-706, Lot Number 59602519
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2302-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026