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.

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.