Z-1588-2010

Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for distal femur in...

Name: Z-1588-2010 Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for distal femur in...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-12-03
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-12-03 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile on 2009-12-03. The reason FDA records is "The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block". 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-1588-2010
Status: Terminated
Initiated: 2009-12-03
Posted: 2010-05-10
Terminated: 2012-09-14
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Product Recall Letters were sent on December 3, 2009 via Federal Express to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. Foreign accounts were notitied on December 7, 2009. Questions or comments should be addressed to Colleen O'Meara at 201-972-2100.
Quantity in commerce: 3056 Duracon Cutting Blocks, total
Distribution: Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.
Product codes and lots: Catalog number: 8000-7050, all lots

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)