Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 1
FDA device recall Z-2135-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
- Action taken
- The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 400 screws
- Distribution
- Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.
- Date initiated
- 2007-07-09
- Date posted
- 2008-09-11
- Date terminated
- 2010-02-03
- Location
- Hillsboro, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONGRUENT BONE PLATE SYSTEM (K012655) | Acu Med, Inc. | 2001-11-07 |
| CORTICAL BONE SCREW (K942340) | Acu Med, Inc. | 1994-12-05 |
| CANNULATED CANCELLOUS BONE SCREW (K942341) | Acu Med, Inc. | 1994-12-05 |