Recall Z-0628-2014 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Materialise USA LLC
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
| Date | Jan 3, 2014 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. |
| Root cause | Nonconforming Material/Component |
| Action | 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 734-662-505 |
| Quantity | 1 |
| Distribution | US Distribution: MO only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110415 | SIGNATURE PLANNER / SIGNATURE GUIDES Materialise NV, May 16, 2011 |