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Materialise USA LLC recalls Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Recalled June 15, 2016 · FDA recall Z-1941-2016 · Materialise USA
Hazard
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. · FDA Class II
Units
1
Sold at
One consignee, Indiana.
Description
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.
Product
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Manufacturer(s)
Materialise USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →