Persona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
Zimmer, Inc. is recalling the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Lot 66232947) after a complaint reported a posterior augment found inside the distal augment package.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of an orthopedic implant component with a packaging/assembly defect. The firm explicitly reported no clinical impact from the complaint, meaning no injury or adverse health consequence has been identified. The hazard is limited to potential confusion or incorrect component identification, which falls under moderate-severity precautionary recalls.
Plain-English summary
Zimmer, Inc. is recalling the Persona Revision Trabecular Metal Femoral Distal Augment, Model No. 42-5572-066-10, Lot number 66232947. The company received a complaint in which a posterior augment was found within the distal augment package.
The firm reported that this complaint had no clinical impact. Twelve units of this product were affected. The specific consignees and distribution history are identified in the attached distribution documentation referenced in the recall notice.
Patients or healthcare providers who have this product should contact Zimmer, Inc. for further guidance or product replacement if needed.
The recalled product
- Product
- Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 12
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)
- Lot Code: Model No. 42-5572-066-10
- UDI-DI (01)00889024561014(17)331103(10)66232947
- Lot number 66232947
Distribution
Distribution scope not specified by the agency.
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