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Recall Observatory FDA recall evidence

Device product

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Z-1941-2016

May 03, 2016

Class II

Product summary

Firm
Materialise USA LLC
Event
Event 74213
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1941-2016

Official wording

Reason: 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.

Code information: Lot #154970

Distribution pattern: One consignee, Indiana.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.