Reported Apr 10, 2019 · Terminated
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
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 Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
- Lot codes and dates
- Serial Numbers 0434436 and 0434836
- Amount recalled
- 2
Where it was sold
Why it was recalled
The labeling of the boxes and sterile pouches did not match the contents.
This product could cause temporary or reversible health problems — stop using it.
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