Z-0380-2013Class II

Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE...

Name: Z-0380-2013 Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE...
Creator: Stryker Spine
Published: 2012-08-09
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-08-09 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com... on 2012-08-09. FDA classified it as Class II and gives the reason as "Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening". 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-0380-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-11-19
Terminated: 2015-09-30
Recalling firm: Howmedica Osteonics Corp
Product: Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Spine sent an Urgent Medical Device Removal Notification letter/Product Accountability Forms dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 201-760-8150.
Quantity in commerce: 54
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Product codes and lots: Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0380-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0380-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0381-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0382-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

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)