FDA Device recall Z-0828-2015
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purp…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purp… by Mako Surgical, citing MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-07 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mako Surgical |
| Distribution | US |
Product
RESTORIS PST Straight Shell Inserter 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
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Identifiers
| code_info | Part Number: 112710, Lot Numbers: 120027, 120041, 120052, 120074, 120076 and 120075. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2015%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.