Z-1778-2008

Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive...

Name: Z-1778-2008 Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-04-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-04-15 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ 07430 Authorized representative in... on 2005-04-15. The reason FDA records is "The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1778-2008
Status: Terminated
Initiated: 2005-04-15
Posted: 2008-08-27
Terminated: 2008-09-24
Recalling firm: Howmedica Osteonics Corp
Product: Xcelerate Patella System Reamer Shaft Assembly; 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: HTO Reamer
Reason for recall: The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order.
Quantity in commerce: 24 total
Distribution: Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.
Product codes and lots: Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.

Product code HTO

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)