FDA Device recall Z-1644-2018
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements by Mako Surgical, citing incorrect product and/or label. Sizing is labeled incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1644-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-01 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY |
Product
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Reason
Incorrect product and/or label. Sizing is labeled incorrectly.
Identifiers
| code_info | Size 2 Item # 180612 Lot # 26080317-01 and Size 7 Item # 180617 Lot # 26150217-01. |
|---|
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-1644-2018%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.