Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of th
FDA device recall Z-0276-2016 · posted 2015-11-14 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
- Action taken
- Communication to the accounts having record of receiving this product was sent on October 19, 2015.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 267
- Distribution
- Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
- Date initiated
- 2015-10-19
- Date posted
- 2015-11-14
- Date terminated
- 2016-08-26
- 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 |
|---|---|---|
| SYNTHES STERNAL ZIPFIX SYSTEM (K110789) | Synthes (Usa) | 2011-07-28 |