FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey
- Recall number
- Z-0450-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey
- Status
- Terminated
- Initiated
- 2006-09-19
- Posted
- 2007-12-11
- Terminated
- 2008-01-18
- Reason
- Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.
- Root cause
- Device Design
- Action
- Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.
- Quantity
- 2,868 units total for Recalls Z-0448-0450-2008
- Distribution
- Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.
- Lot, serial or model codes
- Catalog Number: 6541-5-723; All lot codes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JWH
- 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