GMK Efficiency - GMK Sphere CR Insert Instrument Set recall
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Why was GMK Efficiency - GMK Sphere CR Insert Instrument Set recalled?
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- Recalling firm
- Medacta Usa Inc
- Quantity
- 50 units
- Distribution
- Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
- Recall date
- June 15, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)