Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
FDA Recall Z-1287-2015 · Posted 2015-03-17
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Recalling FirmMaterialise N.V.
Recall StatusTerminated
Product CodeJWH
Date Initiated2015-02-04
Date Terminated2015-10-30
Product Quantity1 unit
Reason for Recall
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
Firm Action
Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution to the Netherlands only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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