Z-0349-2018 Class II Terminated
FDA device recall Z-0349-2018 was initiated by Zimmer Biomet, Inc. on July 5, 2017 and is designated Class II. 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 kn… The recall status is terminated (terminated April 2, 2019). Affected quantity: 158 devices.
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.