GMK Efficiency — Class II medical device recall Z-1247-2022
Terminated recall by Medacta Usa Inc, reported 2022-06-15, distributed in AK, CA, CT, IN, MA, NJ, PA. A Size 2 trial baseplate was assembled with Size 1 instrument sets.
| Recall number | Z-1247-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2022-04-13 |
| Classified | 2022-06-07 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2023-10-23 |
| Distributed | AK, CA, CT, IN, MA, NJ, PA |
| Quantity | 50 units |
| UPC / GTIN / UDI-DI | 07630971252509 |
| Lot numbers | 2109258 |
| Expiration dates | 2026-06-24, 2026-10-04, 2026-10-27 |
Product
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Reason for recall
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1247-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.