GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medacta Usa Inc
- Reason for Recall:
- A Size 2 trial baseplate was assembled with Size 1 instrument sets.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Product Codes/Lot Numbers:
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)
Distribution:
Distributed in: AK, CA, CT, IN, MA, NJ, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1247-2022
Related Recalls
There is a potential for breakage of the small screw used to affix the anti-backout plate.
There is a potential for breakage of the small screw used to affix the anti-backout plate.
There is a potential for breakage of the small screw used to affix the anti-backout plate.