Persona Partial Knee System, Size 8, Finishing Guide
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling the Persona Partial Knee System Size 8 Finishing Guide due to a design issue where the finishing guide does not adequately account for shape differences in Size 8. This problem could result in additional surgery time or patients experiencing tightness during knee flexion. A total of 158 devices were affected across two lot numbers: Lot No. 63518668 (Item No. 42578100801) and Lot No. 63518669 (Item No. 42578100802).
The affected devices were distributed domestically to hospitals and medical facilities in Arizona, California, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, New Jersey, New Mexico, Pennsylvania, South Carolina, Texas, Washington, and Wisconsin. International distribution included Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, and the United Kingdom. The recall record does not specify what remedy an affected consumer should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: 158 devices Lot/code info: Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.