Zimmer Recalls Persona Knee System Tibial Drill Guide
Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of tibial bone fracture, which constitutes a significant injury report under the severity rubric.
Plain-English summary
Zimmer, Inc. is recalling 94 units of the Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter. The affected product is nonsterile and is used with the Persona Knee System for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.
The recall is being conducted to reduce the risks of tibial perforation, which could result in tibial bone fracture due to the stress riser created by a perforation, as well as tibial plate loosening. The recall includes 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.
The affected units were distributed nationwide in the United States and internationally to Germany and Europe. The specific part number is 42-5399-020-00, and the affected lot numbers are 62059525 and 62087055. Healthcare providers and patients should contact Zimmer, Inc. for replacement with enhanced products and instruments.
The recalled product
- Product
- Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
- Manufacturer
- Zimmer, Inc.
- Affected units
- 94
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part Number 42-5399-020-00
- Lot 62059525
- 62087055
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · bone fracture
See all →- HighFathom Pedicle Retractor Blades Recalled for Manufacturing Defect
FDA (Devices) · 2024-07-10
- HighKnee Patella Drills Recalled for Incorrect Diameter Markings
FDA (Devices) · 2023-04-19
- HighShoulder Surgical Navigation System Warning for Bone Stability
FDA (Devices) · 2022-12-14
- HighSmith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch
FDA (Devices) · 2019-04-03
- SevereSmith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch
FDA (Devices) · 2019-04-03