Navigation System II-Cart — Class II medical device recall Z-1810-2015
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2015-06-24, distributed nationwide. Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a
| Recall number | Z-1810-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2015-05-04 |
| Classified | 2015-06-16 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 72 |
| Serial numbers | 100019, 100105, 100106, 100133, 100134, 100214, 100227, 100236, 100237, 100248, 100295, 100417, 100463, 100492, 100493, 100641, 100649, 100704, 100728, 100773, 100797, 100939, 100940, 100941, 100942 and 45 more |
Product
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
Reason for recall
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
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-1810-2015. 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.