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Medacta Usa Inc Recall 90074

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

Medacta Usa Inc Recall 90074 Information

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
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