Reported Dec 24, 2014 · Terminated
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic…
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Plantation, FL · 33317-7424
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number206276
- Lot Numbers
60111126020114603031460307126110612 and E453704
- Amount recalled
- Total 404
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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