Z-2967-2018 Class II Terminated
FDA device recall Z-2967-2018 was initiated by Encore Medical, Lp on May 14, 2018 and is designated Class II. Reason for recall: After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. The recall status is terminated (terminated Aug 17, 2020). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 12, 2018
- Initiation Date
- May 14, 2018
- Termination Date
- Aug 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product Description
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Reason for Recall
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Distribution Pattern
U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
Code Information
All. Lots-866A1011, 866A1022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2967-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026