Z-0480-2021 Class II Ongoing
FDA device recall Z-0480-2021 was initiated by Encore Medical, LP on Jun 19, 2020 and is designated Class II. Reason for recall: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg… The recall status is ongoing. Affected quantity: 28 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 2, 2020
- Initiation Date
- Jun 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product description
EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Reason for recall
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
Distribution pattern
US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
Code information
all lot numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0480-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026