Device 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.
Z-0628-2014
Product summary
- Event
- Event 67039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0628-2014
Official wording
Reason: Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Code information: Lot 094929
Distribution pattern: US Distribution: MO only.
Derived failure modes
-
Unknown
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.