FDA Device recall Z-0829-2015
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically… 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-0829-2015 |
| 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 Acetabular Straight 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
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Identifiers
| code_info | Part Number: 207390, Lot Numbers: 21948201, 21948302, 21948403, 21948501, 21948605 and 21948704. |
|---|
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-0829-2015%22
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