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

Recall Z-1057-2014 — Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hamme

U.S. FDA — Device Enforcement · United States · 2014-01-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1057-2014
Date of alert: 2014-01-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes, Inc.
Product category: device
Product type: Devices

Reported risk: The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.

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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