Reported Apr 8, 2020 · Terminated
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The…
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 PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS
- IPOLY IMPLANT KIT LEFT) 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
- 0460018 0460118
- Amount recalled
- 2
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
This product could cause temporary or reversible health problems — stop using it.
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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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