[Recalled] MOUSE 9732721 STERILE O-ARM 10PK — Medtronic Navigation is recalling certain Medtronic single-use, disposable devi… | FDA 2014-04-24

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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• Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. — Class II
• Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 — Class II
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• Mazor X Surgical System Positioner Type II, REF: ASM0214-02 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.