The Recall Desk

FDA (Devices) recall action 69465

Mako Surgical Corporation recalled 3 products on 2014-12-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-12-24
Critical
0
Units
1,212

Why these products were recalled

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Offset Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged during surgery.

    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.
    Category
    Distribution
    25 states
  • HighFDA (Devices)··2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.

    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.
    Category
    Distribution
    25 states
  • HighFDA (Devices)··2014-12-24

    Mako Surgical Recalls RESTORIS PST Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.

    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.
    Category
    Distribution
    25 states