Z-0325-2017 Class II Terminated
FDA device recall Z-0325-2017 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 current design of the captured box… The recall status is terminated (terminated Oct 20, 2017). Affected quantity: 436 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 9, 2016
- Initiation Date
- Sep 19, 2016
- Termination Date
- Oct 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 436 units
Product description
Empowr PS Knee System Box Cut Guide; 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. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
Distribution pattern
US
Code information
202351L01, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0325-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026