FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland. The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
- Recall number
- Z-0579-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland. The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
- Status
- Terminated
- Initiated
- 2006-09-21
- Posted
- 2009-01-08
- Terminated
- 2009-01-09
- Reason
- Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.
- Root cause
- Process change control
- Action
- Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance.
- Quantity
- 10
- Distribution
- PA, GA, AL, WI, UT, and OR.
- Lot, serial or model codes
- Lot Code SANMH
- 510(k) numbers
- ["K051380"]
- PMA numbers
- not on file
- Product code
- MBH
- 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