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[Recalled] Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument. — Surgeons have experie

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductStryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
Brand / manufacturerStryker Spine
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0893-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date27 December 2012
EAN / barcode48231326

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

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 Spine

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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