Z-0349-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- July 5, 2017
- Termination Date
- April 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158 devices
Product Description
Persona Partial Knee System, Size 8, Finishing Guide
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.