Recall Z-0349-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-07-05, terminated 2019-04-02. It names one FDA 510(k) clearance: K161592. Product: Persona Partial Knee System, Size 8, Finishing Guide. 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-05
- Terminated
- 2019-04-02
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.