Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, Fran
FDA device recall Z-1685-2009 · posted 2009-08-13 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301
- Action taken
- Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 2 units
- Distribution
- Distributed to 2 Stryker branches.
- Date initiated
- 2007-05-29
- Date posted
- 2009-08-13
- Date terminated
- 2009-08-17
- 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 |