Z-1690-2008

Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive...

Name: Z-1690-2008 Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-03-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-03-18 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe... on 2008-03-18. The reason FDA records is "Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1690-2008
Status: Terminated
Initiated: 2008-03-18
Posted: 2008-09-20
Terminated: 2010-10-25
Recalling firm: Howmedica Osteonics Corp
Product: Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Product Correction notification letters were sent via Federal Express, return receipt to all users on March 18, 2008. Questions should be directed to Rita Intorella, Divisional Regulatory Reporting at (201) 831-5825.
Quantity in commerce: 739 units in US; 1213 units internationally
Distribution: Products were distributed worldwide.
Product codes and lots: All lots manufactured since 1998. Catalog Number 7650-3363. Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)