Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a Recalled by Mako Surgical Corporation Due to MAKO has identified the potential that the shell...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mako Surgical Corporation directly.
Affected Products
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.
Quantity: Total 404
Why Was This Recalled?
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mako Surgical Corporation
Mako Surgical Corporation has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report