---
title: "GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 — FDA record Z-1247-2022 | Is It on Recall"
description: "A Size 2 trial baseplate was assembled with Size 1 instrument sets."
url: https://isitonrecall.com/recall/fda-device-z-1247-2022-gmk-efficiency-gmk-sphere-cr-insert-instrument-set-size-1/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 — FDA record Z-1247-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- **Reason**: A Size 2 trial baseplate was assembled with Size 1 instrument sets.
- **Classification**: Class II
- **Recalling firm**: Medacta Usa Inc
- **Quantity**: 50 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1247-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1247-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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) |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
- [California](https://isitonrecall.com/state/california/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)

## Dates in the source

- **Report date**: Jun 15, 2022
- **Recall initiation date**: Apr 13, 2022
- **Center classification date**: Jun 7, 2022
- **Termination date**: Oct 23, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1247-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medacta Usa Inc records](https://isitonrecall.com/brand/medacta-usa-inc/)