Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0382-2013 — 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 Screws, Rod to Rod Conn

U.S. FDA — Device Enforcement · United States · 2012-08-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0382-2013
Date of alert: 2012-08-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Spine
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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