Z-0054-2011

Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee...

Name: Z-0054-2011 Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-08-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-08-23 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component... on 2010-08-23. The reason FDA records is "Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery". 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-0054-2011
Status: Terminated
Initiated: 2010-08-23
Posted: 2010-10-13
Terminated: 2012-08-30
Recalling firm: Howmedica Osteonics Corp
Product: Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated August 30, 2010, to all consignees/customers (branches/agencies, hospital risk management, hospital Chief of Orthopaedics, surgery) including foreign countries. The letter described the product, problem, and action to be taken by customers. The customers were instructed to complete and return the attached PRODUCT RECALL ACKNOWLEDGMENT FORM via fax to 201-831-6069. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance (201) 972-2100.
Quantity in commerce: 839 (total)
Distribution: Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa
Product codes and lots: 8010-0008

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)