FDA Device recall Z-2213-2023
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit…
- FDA Device
- Class II
- completed
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit… by Materialise N V, citing the wrong tibia guide was included intended for a different patient case.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2213-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-04-26 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Materialise N V |
| Distribution | n/a |
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
Reason
The wrong tibia guide was included intended for a different patient case.
Identifiers
| code_info | UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2213-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.