Spine Referencing Instrumentation — Class II medical device recall Z-3140-2017
Terminated recall by Medtronic Navigation, Inc., reported 2017-09-27, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached
| Recall number | Z-3140-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2017-06-29 |
| Classified | 2017-09-21 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2023-07-24 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AU, BD, BE, BG, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HR, ID, IL, IN, IT, JP, KE, LU, LV, MY, NL, NZ, PH, PL, PT, RO, RU, SE, SG, TH, TR, VN |
| Quantity | 2,051 units |
| Reason classes | device malfunction |
Product
Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.
Reason for recall
Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
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-3140-2017. 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.