Reported Dec 2, 2020 · Terminated
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip…
Conformis, Inc.
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: Conformis, Inc. · 600 Technology Park Dr · Billerica, MA · 01821-4154
Is this the product you have?
- iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the
- following patient specific componentsfemoral stem and single use instrumentation
- Lot codes and dates
Serial numbers 04692550469255
- Amount recalled
- 2
Where it was sold
Why it was recalled
Incorrect hip components were provided in kits.
This product could cause temporary or reversible health problems — stop using it.
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