FDA-Device2016-06-15Class II
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Materialise USA LLC
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.
Sold states
One consignee, Indiana.
Affected count
1
Manufactured in
44650 Helm Ct, N/A, Plymouth, MI, United States
Products
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2016Don't want to check this manually?
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