Device product
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
Z-2213-2023
Product summary
- Firm
- Materialise N.V.
- Event
- Event 92621
- Status
- Completed
- Classification
- Class II
- Quantity
- 2 Guides
- Official record key
device-enforcement:Z-2213-2023
Official wording
Reason: The wrong tibia guide was included intended for a different patient case.
Code information: UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
Distribution pattern: International Distribution to countries of: Germany, Netherlands
Derived failure modes
-
Unknown
The wrong tibia guide was included intended for a different patient case.