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

Recall Z-1210-2013 — Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is the

U.S. FDA — Device Enforcement · United States · 2013-03-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1210-2013
Date of alert: 2013-03-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Howmedica Osteonics Corp.
Product category: device
Product type: Devices

Reported risk: Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.

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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