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Recall Observatory FDA recall evidence

Device product

Persona Partial Knee System, Size 8, Finishing Guide

Z-0349-2018

July 05, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 78725
Status
Terminated
Classification
Class II
Quantity
158 devices
Official record key
device-enforcement:Z-0349-2018

Official wording

Reason: 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.

Code information: Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.