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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- 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
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