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Terminated

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.

FDA Recall Z-0790-2016 · Posted 2016-02-09

Recalling FirmRichard Wolf Medical Instruments Corp.
Recall StatusTerminated
Product CodeHRX
Date Initiated2015-11-25
Date Terminated2017-08-21
Product Quantityfour units

Reason for Recall

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.

Firm Action

The firm sent an URGENT Medical Device Recall letter dated 11/25/2015 to consignees informing them of the recall and the actions needed to be taken. These included to not use the affected burr and to destroy the device. The user is also instructed to fill out the Recall Action Response Form to acknowledge receipt of the notification. The form should be scanned to [email protected] or mailed to: Dawn Santostefano, Recall Coordinator Richard Wolf Medical instruments 353 Corporate Woods Parkway Vernon Hill, IL 60061

Root Cause

Process control

Distribution Pattern

Distributed in Washington.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984304RIWO DRIVE GENERATORRichard Wolf Medical Instruments Corp. · 1999-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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