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

Recall Z-0790-2016 — Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded 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.

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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0790-2016
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
Barcode (EAN/GTIN)
0207201502
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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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