Z-0766-2017 Class II Terminated
FDA device recall Z-0766-2017 was initiated by Encore Medical, Lp on Sep 19, 2016 and is designated Class II. Reason for recall: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The recall status is terminated (terminated Oct 20, 2017). Affected quantity: 162 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 21, 2016
- Initiation Date
- Sep 19, 2016
- Termination Date
- Oct 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162 units
Product description
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Reason for recall
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
Distribution pattern
Nationwide Distribution
Code information
202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0766-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026