FDA Device recall Z-0349-2018
Persona Partial Knee System, Size 8, Finishing Guide
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Persona Partial Knee System, Size 8, Finishing Guide by Zimmer Biomet, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0349-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-05 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI |
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.
Identifiers
| code_info | Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0349-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.