Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel… — Class II medical device recall Z-1989-2015
Terminated recall by Alliance Partners LLC, reported 2015-07-15, distributed nationwide. Inadequate interference between the screw and the plate when screw implanted into the plate at angulation grea
| Recall number | Z-1989-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alliance Partners LLC, San Antonio, TX, United States |
| Recall initiated | 2015-06-09 |
| Classified | 2015-07-07 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2015-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 21 units |
| Lot numbers | SM59161, SM60278 |
Product
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis.
Reason for recall
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
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-1989-2015. 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.