Z-0042-2018 Class II Terminated
FDA device recall Z-0042-2018 was initiated by Encore Medical, Lp on Sep 15, 2017 and is designated Class II. Reason for recall: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. The recall status is terminated (terminated Aug 29, 2023). Affected quantity: 46 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 1, 2017
- Initiation Date
- Sep 15, 2017
- Termination Date
- Aug 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product description
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Reason for recall
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Distribution pattern
US Nationwide Distribution
Code information
Lot Number 055U1003
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0042-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026