Zimmer Persona Trabecular Metal Tibial Plate Recall for Loosening Complaints
Zimmer, Inc. is recalling Persona Trabecular Metal Tibial Plates due to increased complaints of loosening and radiolucent lines.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loosening) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer, Inc. is recalling the Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis. This medical device is a knee prosthesis used in posterior cruciate retaining or sacrificing surgical procedures. The recall covers 11,658 units of all lots and sizes C-J, both left and right.
The recall was initiated due to an increase in complaints regarding loosening and radiolucent lines. Radiolucent lines are visible gaps on X-rays that can indicate a lack of bone-to-implant integration or early signs of implant failure.
The affected devices were distributed worldwide, including in the United States, Canada, Australia, New Zealand, and various European and Middle Eastern countries. They were also distributed to Department of Defense and Veterans Affairs hospitals. Consumers and healthcare providers should contact Zimmer, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 11,658
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 (2)
- All lots and sizes
- Sizes C-J Left and Right.
Distribution
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