The Recall Desk
HighFDA (Devices)·Z-1810-2015·Announced 2015-06-24

Stryker Recalls Navigation System II-Cart Due to Weld Seam Defect

Stryker is recalling 72 Navigation System II-Carts because a weld seam defect may cause the articulated arm joint to fail.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical device that could lead to joint failure, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 72 units of the Navigation System II-Cart (model 7700-100-000) equipped with Articulated Arm Cameras (models 7700-103-001 and 7700-103-001U). The recall was initiated because the weld seam between the main stud and the two flaps on the Articulated Arm may not have been welded in the correct location. This defect may result in a potential failure of the arm joint.

The affected devices were distributed worldwide, including in the United States (AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY) and in Canada, Europe, and Asia. The Navigation System II-Cart is intended to be used as a platform for computer-assisted surgery as part of the Stryker Navigation System.

Healthcare facilities and users should stop using the affected devices and contact Stryker for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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 Syst
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Navigation System
Hazard
Affected units
72

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers 100019
  • 100984
  • 100965
  • 100295
  • 100979
  • 100773
  • 100946
  • 100797
  • 100947
  • 100956
  • 100966
  • 100649
  • 100967
  • 100944
  • 100941
  • 100945
  • 100970
  • 100950
  • 100976
  • 100951

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

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