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Terminated

Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.

FDA Recall Z-0803-2015 · Posted 2014-12-16

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-10-06
Date Terminated2017-05-08
Product Quantity15 units

Reason for Recall

Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

Firm Action

Stryker Spine sent an Urgent Medical Device Removal Notification/Acknowledgement Form dated 10/6/2014 via Fed Ex. The letter identified the affected product, discussed the product description, product issue, potential hazards, risk mitigations, and actions needed. Customers were asked to read the notice thoroughly and make sure that it is understood. Additionally, they are to complete the enclosed acknowledgement form and fax or e-mail it back.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.

Official Source

View FDA Recall →

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

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