Zimmer Recalls Persona Tibial Drills to Reduce Perforation Risk
Zimmer, Inc. is recalling 135 Persona Tibial Drills and associated tools to reduce the risk of tibial perforation and bone fracture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk of serious injury (tibial bone fracture) from a structural defect, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 135 units of the Persona, The Personalized Knee System, Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile. The recall includes all lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools such as the Tibial Drill Guide, Broach, and Sizing Plate. The specific part number is 42-5399-018-00 and the lot number is 77001868.
The devices are being removed and replaced with enhanced products and instruments to reduce the risk of tibial perforation. A perforation can create a stress riser that may result in tibial bone fracture or tibial plate loosening. The source text does not report any specific injuries or illnesses associated with this recall.
The affected products were distributed nationwide in the United States and internationally to Germany and Europe. Healthcare providers and patients who have used these specific implants or tools should contact Zimmer, Inc. or their medical provider for guidance on replacement and further evaluation.
The recalled product
- Product
- Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 135
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)
- Part Number 42-5399-018-00
- Lot 77001868
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.
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Similar recalls
- SevereZimmer Recalls Cemented Tibial Drills Due to Bone Perforation Reports
FDA (Devices) · 2012-10-10
- HighZimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk
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