Reported Jan 15, 2014 · Terminated
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T…
Materialise USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise USA LLC · 44650 Helm Ct · Plymouth, MI · 48170-6061
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 094929
- Amount recalled
- 1
Where it was sold
Why it was recalled
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
This product could cause temporary or reversible health problems — stop using it.
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