Z-0803-2015Class II

Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final...

Name: Z-0803-2015 Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final...
Creator: Stryker Spine
Published: 2014-10-06
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2014-10-06 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of 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... on 2014-10-06. FDA classified it as Class II and gives the reason as "Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0803-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2014-12-16
Terminated: 2017-05-08
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 15 units
Distribution: Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
Product codes and lots: Lot number 4279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0803-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)