Restoris Multicompartmental Knee — Class II medical device recall Z-1031-2016
Terminated recall by Mako Surgical Corporation, reported 2016-03-09, distributed nationwide. Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibi
| Recall number | Z-1031-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2016-01-15 |
| Classified | 2016-03-01 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB, GR, IT, SG, TR |
| Quantity | 146 |
| Reason classes | sterility |
| Lot numbers | 1388810512, 1388860512, 26010511-01, 26020411-01, 26020812-01, 26040212-01, 26050112-01, 26050211-01, 26050212-01, 26060211-01, 26060311-01, 26061011-01, 26061211-01, 26070212-01, 26070811-01, 26090311-01, 26090512-01, 26090611-02, 2610012-01, 26110111, 26110112-01, 26131111-01, 26140412-01, 26141111-01, 26160212-01, 26160711-01, 26161111-01, 26171111-01, 26180512-01, 26180711-0126120211-01, 26190612-01, 26190911-01, 26210511-02, 26211011-01, 26220512-01, 26220512-02, 26230411-01, 26240711-01, 26250511-01, 26270512-01 and 21 more |
| Model numbers | 180601, 180602, 180603, 180604, 180605, 180606, 180607, 180608, 180611, 180612, 180613, 180614, 180615, 180616, 180617, 180618 |
Product
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Reason for recall
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
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-1031-2016. 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.