Trident Acetabular Hip System Polyethylene Inserts, Stryker… recallZ-0909-2010 · Stryker Howmedica Osteonics Corp. · initiated Feb 17, 2006
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0909-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 17, 2006
- Posted by the FDA
- Mar 2, 2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 594 units total - all products.
- Product code
- LPH
- FDA submissions
- K033716
- Distribution
- Worldwide Distribution -- United States and Canada.
Product description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
8 devices cleared under K033716 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Trident 643-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented8 reports
- Trident 643-00-36FHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate8 reports
- Trident 663-00-32DHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- Trident 663-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Trident 623-10-28CHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented3 reports
- Trident 663-00-36GHowmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trident 663-00-36FHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 50150).
- Z-0911-2010 · TerminatedScorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with cemented or cementless compo…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page