Reported Dec 18, 2019 · Terminated
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement…
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
- CR Knee Replacement System Model NumberTCR-111-1111-010102 -
- Product UsageThe iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
- Lot codes and dates
- Serial Number0450585
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- GA
Why it was recalled
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
This product could cause temporary or reversible health problems — stop using it.
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