3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination wi
FDA device recall Z-0390-2014 · posted 2013-11-26 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
- Action taken
- Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 40248
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada.
- Date initiated
- 2013-07-22
- Date posted
- 2013-11-26
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3.7MM/5.0MM DYNAMIC LOCKING SCREW (K110592) | Synthes USA | 2011-07-25 |