Z-1224-2018 Class II Terminated
FDA device recall Z-1224-2018 was initiated by Zimmer Biomet, Inc. on Dec 12, 2017 and is designated Class II. Reason for recall: A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of… The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Dec 12, 2017
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Reason for Recall
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Distribution Pattern
Non-USA Customer
Code Information
Item# 42-5320-067-02 Lot # 63236047
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1224-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026