Stryker Spine Recalls XIA Torque Wrenches Due to Fracturing Hex Tips
Stryker Spine is recalling XIA and Mantis Redux torque wrenches because the hex tips may fracture during final tightening.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (fracturing hex tip) that poses a risk of harm during surgical procedures, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Spine is recalling specific models of XIA and Mantis Redux torque wrenches. The recall involves the XIA Torque Wrench, XIA 3 Torque Wrench, XIA Elegance Short Torque Wrench, and Mantis Redux Torque Wrench. These devices are intended for use in spinal fixation systems to provide immobilization and stabilization of spinal segments in skeletally mature patients.
The recall was initiated due to multiple complaints reporting that the hex tip of the torque wrench fractures during final tightening. The affected units were distributed worldwide, including nationwide in the United States and internationally to countries such as Argentina, Australia, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
Healthcare providers and facilities should stop using the affected torque wrenches and contact Stryker Spine for further instructions. The recall covers 220 US units and 431 units outside the US. Specific lot numbers and catalog numbers for the affected devices are listed in the official recall documentation.
The recalled product
- Product
- Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine 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 Court Allendale
- Manufacturer
- Stryker Spine
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 092793
- 097089
- 11E038
- 11E039
- 11E040
- 11E041
- 123746
- 127179
- &12D012 2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042
- 11E044
- 11E047
- 098525
- 118823
- 11E043
- 11E045
- 11E046
- 11E048
- 127647
- R127647
- 12A646
Distribution
Distributed nationwide across the United States.
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