The Recall Desk

FDA (Devices) recall action 63386

Stryker Spine recalled 3 products on 2012-11-28

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-11-28
Critical
0
Units
101

Why these products were recalled

Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2012-11-28

    Stryker Mantis Torque Wrench Recalled for Hex Tip Fracture

    Stryker Spine is recalling 19 Mantis Torque Wrenches because the hex tip may fracture during use. The recall covers units distributed in the US and internationally.

    Product
    Stryker MANTIS TORQUE WRENCH REF 48287028 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-11-28

    Stryker XIA 3 Torque Wrench Recalled Due to Hex Tip Fracture

    Stryker Spine is recalling 54 XIA 3 Torque Wrenches because the hex tip may fracture during use, posing a risk of injury to patients or providers.

    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-11-28

    Stryker Spine Recalls Specialty Audible Torque Wrenches Due to Fracturing Tips

    Stryker Spine is recalling 28 units of Specialty Audible Torque Wrenches because the hex tips have fractured during use.

    Product
    SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 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…
    Category
    Distribution
    0 states