Recall Z-0380-2013
Stryker Spine · initiated August 9, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
Reason for recall
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0380-2013
- Initiated
- August 9, 2012
- Posted by FDA
- November 19, 2012
- Terminated
- September 30, 2015
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 54
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0381-2013 Class II | Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I…Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. | 08/09/2012Terminated |
| Z-0382-2013 Class II | SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT…Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. | 08/09/2012Terminated |