Reported Jun 15, 2016 · Terminated
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Materialise USA LLC
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: Materialise USA LLC · 44650 Helm Ct · Plymouth, MI · 48170-6061
Is this the product you have?
- Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
- Lot codes and dates
- Lot #154970
- Amount recalled
- 1
Where it was sold
Why it was recalled
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
This product could cause temporary or reversible health problems — stop using it.
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