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Terminated

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.

FDA Recall Z-0893-2013 · Posted 2013-02-28

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2012-12-27
Date Terminated2015-09-30
Product Quantity46 units US

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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