Saw Sagittal Catalog Number: ES 300 — Class II medical device recall Z-2085-2016
Terminated recall by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, reported 2016-07-06, distributed in AL, AR, AZ, CA, CT, FL, GA, IA…. Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for le
| Recall number | Z-2085-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, Haltom City, TX, United States |
| Recall initiated | 2016-05-13 |
| Classified | 2016-06-28 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-06-13 |
| Distributed | AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, UT |
| Quantity | 368 devices |
| Reason classes | packaging |
| Model numbers | 300, ES300-R, ES310, ES310-R |
Product
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
Reason for recall
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
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-2085-2016. 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.