Z-1257-2022 Class II Ongoing
FDA device recall Z-1257-2022 was initiated by Encore Medical, LP on May 5, 2022 and is designated Class II. Reason for recall: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. The recall status is ongoing. Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- May 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Reason for Recall
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Distribution Pattern
U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
Code Information
Lot number 078T1141
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1257-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026