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

Recall Z-0610-2013 — Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the

U.S. FDA — Device Enforcement · United States · 2012-08-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0610-2013
Date of alert: 2012-08-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Howmedica Osteonics Corp.
Product category: device
Product type: Devices

Reported risk: During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.

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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