Persona recall
Persona Partial Knee System, Size 8, Finishing Guide
Why was Persona recalled?
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
- Product
- Persona Partial Knee System, Size 8, Finishing Guide
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 158 devices
- Distribution
- Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)