Z-0893-2013Class II

Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head...

Name: Z-0893-2013 Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head...
Creator: Stryker Spine
Published: 2012-12-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-12-27 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of 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... on 2012-12-27. FDA classified it as Class II and gives the reason as "Surgeons have experienced unthreading of the screwdrivers outer shafts during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0893-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-27
Posted: 2013-02-28
Terminated: 2015-09-30
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Spine sent a "Urgent Medical Device Removal" letter dated January 14 2013, via FedEx overnight to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine your inventory and hospital inventory locations to identify your product. Please fax a copy of the Customer Response form to (855) 632-9049 to Regulatory Compliance. For further questions please call (201) 760-8298.
Quantity in commerce: 46 units US
Distribution: 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.
Product codes and lots: Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0893-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0893-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-28

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)