Recall record at a glance
| Official record | Z-1715-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Report date | Jun 11, 2014 |
| Recall initiation date | May 13, 2014 |
| Quantity | 20 |
| Location | Portage, MI, United States |
Official product description
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.
Why the product was recalled
The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints
Distribution information
Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: not stated.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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