MRI Biomet Pin Guide for Total Knee Arthroplasty — Class II medical device recall Z-2213-2023
Completed recall by Materialise N.V., reported 2023-07-26. The wrong tibia guide was included intended for a different patient case.
| Recall number | Z-2213-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise N.V., Heverlee, N/A, Belgium |
| Recall initiated | 2023-04-26 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Countries outside the US | DE, NL |
| Quantity | 2 guides |
| UPC / GTIN / UDI-DI | 05420060310027 |
| Model numbers | KNM-ZB02-00-01 |
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 for recall
The wrong tibia guide was included intended for a different patient case.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2213-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.