RESTORIS PST Acetabular Offset Shell Impactors An impactor is a… — Class II medical device recall Z-0830-2015
Terminated recall by Mako Surgical Corporation, reported 2014-12-24, distributed nationwide. MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
| Recall number | Z-0830-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2014-10-07 |
| Classified | 2014-12-18 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2016-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 404 |
| Lot numbers | 6011112, 6020114, 6030314, 6030712, 6110612, E453704 |
| Model numbers | 206276 |
Product
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Reason for recall
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
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-0830-2015. 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.