Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic Recalled by Mako Surgical Corporation Due to Potential disassociation of the orientation pin.
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 RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Quantity: 96
Why Was This Recalled?
Potential disassociation of the orientation pin.
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