Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, t
FDA device recall Z-2794-2015 · posted 2015-09-18 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.
- Action taken
- Synthes sent an Urgent Notices of Medical Device Recall letter, dated August 11, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return affected devices and response forms. For further questions please call (610) 719-6500.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 40038
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-08-11
- Date posted
- 2015-09-18
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3.7MM/5.0MM DYNAMIC LOCKING SCREW (K110592) | Synthes USA | 2011-07-25 |