Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to
FDA device recall Z-0086-2008 · posted 2007-11-07 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Action taken
- Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 776 units.
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
- Date initiated
- 2007-08-02
- Date posted
- 2007-11-07
- Date terminated
- 2008-01-09
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS (K953510) | Encore Orthopedics, Inc. | 1995-08-09 |