Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1583-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2016-02-23 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1583-2016
Date of alert
2016-02-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mako Surgical Corporation
Product category
device
Product type
Devices
Reported risk: Potential disassociation of the orientation pin.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.