FDA Device recall Z-1807-2018
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis by Zimmer Biomet, citing there is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if crac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1807-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-07 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Reason
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Identifiers
| code_info | Lot 63693589, UDI (01)00889024247574(10)63693589; Lot 63649575, UDI (01)00889024247574(10)63649575; Lot 63576035, U…Lot 63693589, UDI (01)00889024247574(10)63693589; Lot 63649575, UDI (01)00889024247574(10)63649575; Lot 63576035, UDI (01)00889024247574(10)63576035; Lot 63531869, UDI (01)00889024247574(10)63531869 |
|---|
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-1807-2018%22
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