MRI Biomet Pin Guide (Materialise) – Wrong Guide (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Materialise N.V. Technologielaan 15 Heverlee Belgium
Lot Codes / Batch Numbers
UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
Products Sold
UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
Materialise N.V. Technologielaan 15 Heverlee Belgium is recalling MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- due to The wrong tibia guide was included intended for a different patient case.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The wrong tibia guide was included intended for a different patient case.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026