MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev
Summary
The FDA issued a Class II for MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific by Materialise N.V.. Reason: The wrong tibia guide was included intended for a different patient case..
Details
Source
Device Recall
External ID
Z-2213-2023
Action Date
2023-07-26
Status
Completed
Category
device
Product Description
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
Lot/Code Info: UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
Quantity Affected: 2 Guides
Reason for Recall
The wrong tibia guide was included intended for a different patient case.
Distribution
International Distribution to countries of: Germany, Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-26
Company
Heverlee, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Materialise N.V. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Materialise N.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Materialise N.V. have FDA actions?
Materialise N.V. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2213-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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