Product Safety Recalls

Product Recall Tracker

Medacta Usa Inc Recall 90074

Description: GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Medacta Usa Inc Recall 90074 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1247-2022
Event ID90074
Event DescriptionGMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Product TypeDevices
DistributionDistribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Quantity50 units
Recall ReasonA Size 2 trial baseplate was assembled with Size 1 instrument sets.
Device Classification20220615
Device Code InfoModel Number/Reference Code: 11.01041; UDI-DI: 07630971252509; Lot Numbers Lots: 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), 2115530 (exp. 10/27/2026)
Center Classification Date20220607
Recall Initiation Date20220413
Recalling FirmMedacta Usa Inc
Initial Notification E-Mail
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.