FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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
- Recall number
- Z-1778-2008
- Recalling firm
- Stryker 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
- Status
- Terminated
- Initiated
- 2005-04-15
- Posted
- 2008-08-27
- Terminated
- 2008-09-24
- Reason
- 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
- 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
- 24 total
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.
- Lot, serial or model codes
- Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28