Stryker ACM — Class II medical device recall Z-2598-2023
Ongoing recall by Stryker Corporation, reported 2023-09-27, distributed nationwide. Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble
| Recall number | Z-2598-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2023-08-07 |
| Classified | 2023-09-18 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, ES, FR, GB, HK, IT, KR, MY, PL, SG, TH, TW |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04546540055408 |
| Lot numbers | 22305012, 22306012, 22307012, 22308012, 22311012, 22315012, 22316012, 22318012, 22319012, 22320012, 22321012, 22322012, 22323012, 22325012, 22326012, 22327012, 22332012, 22333012, 22334012, 22335012, 22336012, 22337012, 22340012, 22341012, 22342012, 22346012, 22347012, 22348012, 22351012, 22353012, 22354012, 22355012, 22356012, 22357012, 22361012, 22362012, 22363012, 22364012, 23003012, 23004012 and 11 more |
| Model numbers | 0306-563-000 |
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
Reason for recall
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
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-2598-2023. 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.