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

Reuseable rotary blade/abrader, product number 899751305 — recall Z-0789-2016

U.S. FDA — Device Enforcement · United States · 2015-11-25 · Class II

As described by U.S. FDA — Device Enforcement: Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0789-2016
Date of alert
2015-11-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Richard Wolf Medical Instruments Corp.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in Washington.
Barcode (EAN/GTIN)
899751304
Reported risk: Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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