Recall Z-2213-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise N.V.
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
| Date | Jul 20, 2023 (initiated Apr 26, 2023) |
| Status | Completed |
| Reason | The wrong tibia guide was included intended for a different patient case. |
| Root cause | Process control |
| Action | Materialise notified Zimmer Biomet international logistics on April 26, 2023 via email and telephone requested return of cases. Zimmer BIomet confirmed that they would directly contact the customer to return the original cases ZB23-MAN-OLA and ZB22-UHI-NEF. Materialise shipped replacement cases on May 2, 2023 and May 3, 2023. For questions call +1-734-259-7010 or email: zimmerbiomet@materialise.com. |
| Quantity | 2 Guides |
| Distribution | International Distribution to countries of: Germany, Netherlands |
| FDA record | Open on fda.gov |