CLASS II Device recall · Reported 6 Mar 2013 · FDA Enforcement Report

Stryker XIA 3 Iliac Screwdriver The XIA 3 Iliac Screwdriver recalled

Stryker Spine is recalling Stryker XIA 3 Iliac Screwdriver The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed, distributed nationwide in the US. The recall was initiated on 27 Dec 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.

Quantity recalled46 units US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0893-2013
FDA event ID: 64313
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 27 Dec 2012
FDA classified: 28 Feb 2013
Reported: 6 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

27 Dec 2012	Recall initiated by company
28 Feb 2013	Classified by FDA	+63 days
6 Mar 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.

Nationwide Alabama Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina New York Oklahoma Oregon

Questions about this recall

Is Stryker XIA 3 Iliac Screwdriver The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed recalled?

Yes. Stryker Spine recalled Stryker XIA 3 Iliac Screwdriver The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed on 27 Dec 2012. The recall is Class II and its status is Terminated. Recall number Z-0893-2013.

Why was it recalled?

Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

Which lots are affected?

Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.

Where was it sold?

Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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