Z-0711-2017 Class II Terminated
FDA device recall Z-0711-2017 was initiated by Encore Medical, Lp on Nov 15, 2016 and is designated Class II. Reason for recall: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus. The recall status is terminated (terminated Jan 20, 2017). Affected quantity: 7 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 14, 2016
- Initiation Date
- Nov 15, 2016
- Termination Date
- Jan 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product description
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Reason for recall
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Distribution pattern
US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
Code information
033T1022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0711-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026