Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunio
FDA device recall Z-1274-2014 · posted 2014-03-25 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.
- Action taken
- A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 343
- Distribution
- Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
- Date initiated
- 2014-01-07
- Date posted
- 2014-03-25
- Date terminated
- 2015-09-10
- 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 |
|---|---|---|
| 2.7MM LCP ULNA OSTEOTOMY SYSTEM (K113364) | Synthes (USA) Products, LLC | 2012-02-29 |