Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use i
FDA device recall Z-0909-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 594 units total - all products.
- Distribution
- Worldwide Distribution -- United States and Canada.
- Date initiated
- 2006-02-17
- Date posted
- 2010-03-02
- Date terminated
- 2010-03-03
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIDENT ACETABULAR SYSTEM (K033716) | Howmedica Osteonics Corp. | 2005-02-10 |