FDAFDA · Food and drugs·Recall number Z-1247-2022
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Published June 15, 2022 · Recall initiated: April 13, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Medacta Usa Inc
- Distributor
- Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
- Lot
- Model 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.