Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of th
FDA device recall Z-2475-2015 · posted 2015-08-27 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- The end cap may loosen and detach making the instrument non-functional. No injuries reported.
- Action taken
- Urgent recall notification letters, dated July 22, 2015 were sent to end users and consultants to inform them of the issue, the associated risks, and provided instructions to return affected devices along with the response form.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 451
- Distribution
- Nationwide and internationally to Canada.
- Date initiated
- 2015-07-22
- Date posted
- 2015-08-27
- 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 |
|---|---|---|
| SYNTHES STERNAL ZIPFIX SYSTEM (K110789) | Synthes (Usa) | 2011-07-28 |