Z-0791-2016Class II

Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or...

Name: Z-0791-2016 Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2015-11-25
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2015-11-25 / Terminated / root cause: manufacturing process

FDA source

Richard Wolf Medical Instruments Corp. began a recall of Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for... on 2015-11-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0791-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-02-09
Terminated: 2017-08-21
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally 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.
Product code: HRX Arthroscope
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 2 units
Distribution: Distributed in Washington.
Product codes and lots: Affected lot 4500166254.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0791-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0789-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09
Z-0790-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09
Z-0791-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09

Product code HRX

K984304Class IIRiwo Drive GeneratorRichard Wolf Medical Instruments Corp. / cleared 1999-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)