Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head
FDA device recall Z-0126-2016 · posted 2015-10-15 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
- Action taken
- DePuy Synthes sent an urgent notice of medical device recall letter dated September 21, 2015, to all affected customers to notify them about the issue, the potential risks, and to provide instructions for return of the completed response form and affected devices. Customers with questions were instructed to call 610-719-5450.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 793
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-09-21
- Date posted
- 2015-10-15
- Date terminated
- 2016-08-26
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548) | Synthes (USA) Products, LLC | 2014-02-28 |