Restoris Multicompartmental Knee — Class II medical device recall Z-1132-2014
Terminated recall by Mako Surgical Corporation, reported 2014-03-12, distributed nationwide. The product may be mislabeled and could result in the incorrect implant being used.
| Recall number | Z-1132-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2014-01-09 |
| Classified | 2014-03-04 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 41 units |
| Reason classes | labeling |
| Lot numbers | 12151013-1 |
| Model numbers | 180704-1 |
Product
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
Reason for recall
The product may be mislabeled and could result in the incorrect implant being used.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1132-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.