Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments
Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential raw material cracks that could compromise 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 (potential cleanliness compromise in a surgical instrument) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical hazards.
Plain-English summary
Zimmer Biomet, Inc. is recalling 842 units of the Persona Stemmed Tibial Provisional Size H Right (Item Number 42532108302). These medical devices are intended for use during orthopaedic surgery for the implantation of a prosthesis. The affected products are identified by Lot 63683139 and Lot 63613121.
The recall was initiated because there is a potential for intermittent cracks in the raw material batch used to produce these instruments. If these cracks penetrate the surface of the instrument, the cleanliness of the affected products could be compromised.
The products were distributed worldwide, including nationwide in the United States to specific states and Puerto Rico, as well as to Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, the Netherlands, and Singapore. Healthcare providers and facilities should stop using the affected lots and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 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 (4)
- Lot 63683139
- UDI (01)00889024246942(10)63683139
- Lot 63613121
- UDI (01)00889024246942(10)63613121
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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