FDAFDA · Food and drugs·Recall number Z-0628-2014
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.
Published January 15, 2014 · Recall initiated: November 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Materialise USA LLC
- Distributor
- US Distribution: MO only.
- Lot
- Lot 094929
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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