Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated; Multiholed; Use with Size A inse
FDA device recall Z-1168-2008 · posted 2008-06-12 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Action taken
- Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 129,312 total shells, all Trident hemispherical types
- Distribution
- Nationwide distribution.
- Date initiated
- 2008-01-21
- Date posted
- 2008-06-12
- Date terminated
- 2012-09-25
- 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 HEMISPHERICAL ACETABULAR SHELLS (K013676) | Howmedica Osteonics Corp. | 2001-12-05 |