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

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630 — recall Z-1759-2018

U.S. FDA — Device Enforcement · United States · 2018-04-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1759-2018
Date of alert
2018-04-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10886982070630
Reported risk: There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.