Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1810-2015 — 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

U.S. FDA — Device Enforcement · United States · 2015-05-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1810-2015
Date of alert: 2015-05-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Instruments Div. of Stryker Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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