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.
This recall has been terminated (originally issued January 3, 2014).
- Company
- Materialise Usa Llc
- Recall Initiated
- November 26, 2013
- Posted
- January 3, 2014
- Terminated
- January 14, 2014
- Recall Number
- Z-0628-2014
- Quantity
- 1
- Firm Location
- Plymouth, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Distribution
US Distribution: MO only.
Lot / Code Info
Lot 094929
Root Cause
Nonconforming Material/Component
Action Taken
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.