Reported Feb 21, 2018 · Terminated
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and…
ConforMIS, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConforMIS, Inc. · 28 Crosby Dr · Bedford, MA · 01730-1402
Is this the product you have?
- Total Knee Replacement , Catalog/Model # TPS-111-1111
- UDI+M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ 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 numbers0398482 & 0399917
- Expiration Date12/31/2017
- Amount recalled
- 2 units
Where it was sold
Why it was recalled
Implant kit mislabeled
This product could cause temporary or reversible health problems — stop using it.
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