The Acumed Slide-Loc Anatomic Radial Head System is intended for use… — Class II medical device recall Z-2197-2017
Terminated recall by Acumed LLC, reported 2017-06-07, distributed nationwide. The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System base
| Recall number | Z-2197-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumed LLC, Hillsboro, OR, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-12-01 |
| Distributed | Nationwide (US) |
| Model numbers | 318837, 318838, 318839, 318845, 318846, 318847, 318848, 318850, 318851, 318852, 318853, 318854, 325925, 326011, 326167, 326380, 326381, 327677, 327678, 327820, 327821, 328328, 328329, 340828, 340983 and 292 more |
Product
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
Reason for recall
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
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-2197-2017. 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.