FDA Device recall Z-0595-2020
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665 by Zimmer Biomet, citing possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0595-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-25 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, FL, IN, MN, MO, NY, UT |
Product
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
Reason
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
Identifiers
| code_info | Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366…Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0595-2020%22
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