Z-0928-2011

Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate...

Name: Z-0928-2011 Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-09-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-09-27 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker... on 2010-09-27. The reason FDA records is "Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the "Sizing Guide") to disassociate from the main body of the instrument". 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-0928-2011
Status: Terminated
Initiated: 2010-09-27
Posted: 2011-01-19
Terminated: 2013-07-31
Recalling firm: Howmedica Osteonics Corp
Product: Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the "Sizing Guide") to disassociate from the main body of the instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.
Quantity in commerce: six units
Distribution: Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.
Product codes and lots: Catalog Number 8001-0313 Lot # RD3N198 & Lot #RD3N200

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)