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

Recall Z-1916-2018 — Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

U.S. FDA — Device Enforcement · United States · 2018-05-04 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1916-2018
Date of alert
2018-05-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Reported risk: The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
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.

Related

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.