Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks
Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units due to potential cracks in the raw material that could compromise product cleanliness.
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-harm product (medical device) where the hazard is a potential cleanliness compromise due to material cracks, but no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 842 units of the Persona Cemented Tibial SZ PLT Size H Left (Item Number 42539908301). These orthopaedic prostheses are intended for use during surgery for implantation. The recall covers specific lots: 63693589, 63649575, 63576035, and 63531869.
The recall was initiated because there is a potential for intermittent cracks in the raw material batch used to produce these products. If these cracks penetrate the surface of the instrument, the cleanliness of the affected products could be compromised.
The affected products were distributed nationwide in the United States to numerous states and Puerto Rico, as well as internationally to Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, the Netherlands, and Singapore. Healthcare providers and patients should check their inventory or surgical records for the specific item number and lot numbers listed above. If the product is identified, it should be removed from use and returned to the manufacturer or an authorized distributor.
The recalled product
- Product
- Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 842
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 (8)
- Lot 63693589
- UDI (01)00889024247574(10)63693589
- Lot 63649575
- UDI (01)00889024247574(10)63649575
- Lot 63576035
- UDI (01)00889024247574(10)63576035
- Lot 63531869
- UDI (01)00889024247574(10)63531869
Distribution
Part of a larger recall action
This product is one of 4 recalled by Zimmer Biomet, 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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