REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

Materialise USA LLC notified the Field Representative on November 26, 2013 of the recall by phone followed by E-mail notification. The notification identified the device and reason for the recall. Notification directions included instructions to find and quarantine the device and return it Materialise. A replacement device was shipped November 27, 2013 receiving the defective device was called, followed by E-mail notification the Recall, which identified the device, problem, and instructed the distributor to find and quarantine product. For questions regarding this recall call 734-662-5057.