Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use
FDA device recall Z-0557-2010 · posted 2009-12-22 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
- Action taken
- Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 786 total stems
- Distribution
- Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
- Date initiated
- 2009-01-14
- Date posted
- 2009-12-22
- Date terminated
- 2012-07-18
- 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 |
|---|---|---|
| SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS (K020615) | Howmedica Osteonics Corp. | 2002-05-13 |