Z-0041-05

Ultra Power Burs, Sterile, Single-Use

Name: Z-0041-05 Ultra Power Burs, Sterile, Single-Use
Creator: Linvatec Corp.
Published: 2004-08-26
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2004-08-26 / Terminated / root cause: packaging

FDA source

Linvatec Corp. began a recall of Ultra Power Burs, Sterile, Single-Use on 2004-08-26. The reason FDA records is "The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0041-05
Status: Terminated
Initiated: 2004-08-26
Posted: 2004-10-23
Terminated: 2012-07-06
Recalling firm: Linvatec Corporation
Product: Ultra Power Burs, Sterile, Single-Use.
Product code: HRX Arthroscope
Reason for recall: The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.
Quantity in commerce: 58510 units
Distribution: Distributed to 492 customers throughout the United States, and 301 customers internationally.
Product codes and lots: All product with an expiration date between August 2004 and August 2009.

Product code HRX

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)