Z-0329-2018 Class II Terminated
FDA device recall Z-0329-2018 was initiated by Encore Medical, Lp on Dec 12, 2017 and is designated Class II. Reason for recall: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. The recall status is terminated (terminated Jun 13, 2022). Affected quantity: 2 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 17, 2018
- Initiation Date
- Dec 12, 2017
- Termination Date
- Jun 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product description
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason for recall
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Distribution pattern
One medical device distributor in California.
Code information
Lot 252564
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0329-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026