||November 19, 2012
|Recall Event ID
Orthopedic Manual Surgical Instrument - Product Code LXH
||Stryker MANTIS TORQUE WRENCH
Stryker pine SAS
Distributed in the USA by:
2 Pearl Ct. Allendale
NJ 07401-1677 USA
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.
||Class I device, 510(K) exempt
Catalog Number: 48287028
Lot Number: 098400
2 Pearl Ct
Allendale, New Jersey 07401-1611
|For Additional Information Contact
|Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||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
||Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.