Reported Jul 26, 2023 · Completed
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched…
Materialise N.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise N.V. · Technologielaan 15 · Heverlee, N/A · N/A
Is this the product you have?
- 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
- RefKNM-ZB02-00-01
- Lot codes and dates
- UDI-DI(01)05420060310027
- Lot Number/Case Number
ZB22UHINEFZB23MANOLA
- Amount recalled
- 2 Guides
Why it was recalled
The wrong tibia guide was included intended for a different patient case.
This product could cause temporary or reversible health problems — stop using it.
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