Recall Z-0628-2014— Materialise USA LLC
Class II · Terminated
Class II FDA medical device recall by Materialise USA LLC, initiated 2013-11-26, terminated 2014-01-14. It names one FDA 510(k) clearance: K110415. Product: 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.. Reason: Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert..
- Recalling firm
- Materialise USA LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-26
- Terminated
- 2014-01-14
- Firm location
- Plymouth, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Data sourced from openFDA. This site is unofficial and independent of the FDA.