Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
FDA device recall Z-2810-2015 · posted 2015-09-23 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
- Action taken
- Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 16 units
- Distribution
- Distributed in WI.
- Date initiated
- 2015-06-25
- Date posted
- 2015-09-23
- Date terminated
- 2017-08-30
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIDENT ACETABULAR SYSTEM (K033716) | Howmedica Osteonics Corp. | 2005-02-10 |