FDA recall Z-2213-2023

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.

Distribution

International Distribution to countries of: Germany, Netherlands

Key facts

Status

Completed

Initiation date

2023-04-26

Report date

2023-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Heverlee, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2023