FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.
- Recall number
- Z-0909-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2010-03-02
- Terminated
- 2010-03-03
- Reason
- Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
- Root cause
- Process design
- Action
- Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.
- Quantity
- 594 units total - all products.
- Distribution
- Worldwide Distribution -- United States and Canada.
- Lot, serial or model codes
- Lot Numbers: 36481101; 36491201; 36514901; 36609101; 36517801; 36526201; 36602201; 36422401; 36631201; 36643801; 36425501; 36448901; 36647201; 36737701; 36742301; 36772901; 36775301; 36547101; 36563001; 36473901; 36738101; 36609001; 36466401; 36642601; 36481401 and 36428401.
- 510(k) numbers
- ["K033716"]
- PMA numbers
- not on file
- Product code
- LPH
- 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