Medacta recalls GMK Sphere CR Insert Instrument Set Size 1 due to incorrect baseplate assembly. Affected units have Lot Numbers 2109258, 2111198, or 2115530. Contact for return instructions.
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Medacta is recalling GMK Sphere CR Insert Instrument Set Size 1 products because a Size 2 baseplate was assembled with Size 1 instrument sets. This mismatch could cause improper use during procedures, potentially leading to errors or complications.
The hazard involves assembling a Size 2 baseplate with Size 1 instrument sets. This mismatch could lead to improper fit during medical procedures, potentially causing errors or complications if used incorrectly.
Patients and medical professionals using the GMK Sphere CR Insert Instrument Set Size 1 with Lot Numbers 2109258, 2111198, or 2115530 are affected. Those performing procedures with these instruments are most at risk.
Check the product label for Lot Numbers 2109258, 2111198, or 2115530. The model number is 11.01041 and the UDI-DI is 07630971252509.
Look for Lot Numbers 2109258, 2111198, or 2115530 on the product label.
The model number is 11.01041.
Lot Numbers 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), and 2115530 (exp. 10/27/2026).
The recall does not specify a stop-use action; check the product label for affected lot numbers.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-1247-2022 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-1247-2022 from Medacta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
