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[Recalled] Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. — During a review of the packaging, it was determined that the seal integrity of… | FDA 201

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductStryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Brand / manufacturerStryker Howmedica Osteonics Corp.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0878-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date21 January 2016

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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 →

Related recalls from Stryker Howmedica Osteonics Corp.

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.

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