Z-0540-2013 Class II Terminated
FDA device recall Z-0540-2013 was initiated by Zimmer, Inc. on Nov 14, 2012 and is designated Class II. Reason for recall: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and… The recall status is terminated (terminated Apr 16, 2014). Affected quantity: 518.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 14, 2012
- Termination Date
- Apr 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 518
Product Description
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
Reason for Recall
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
Code Information
Part Number 42-5320-067-01 TIBIA SIZE D, LEFT, Lot: 62018341, 62018342, 62030572, 62030573, 62033385, 62051022, 62068416, 62076576, 62079742, 62091362, 62103717, 62103718, 62110194, 62117656, 11007593, 11007636, 11007592, 11007635, 11007594, 11007634 Part Number 42-5320-067-02 TIBIA SIZE D RIGHT, Lot: 11006514, 11007138, 11007214, 62018343, 62018344, 62033386, 62040513, 62060743, 62068417, 62076577, 62079743, 62079744, 62091363, 62103720, 62117657, 11007589, 11007590, 11007591, 11007637, 11007638, 11007639, 62140222
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0540-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026