Recalls / —
—#141160
Product
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
- FDA product code
- JDQ — Cerclage, Fixation
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K110789
- Affected lot / code info
- Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659168, 7666085, 7671934, 7689244, 7694377, 7720599, 7738572, 7738573, 7740498, 7767497, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 8068078, 8130898, 8145793, 8207769, and 8215969.
Why it was recalled
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.
Root cause (FDA determination)
Device Design
Action the firm took
Communication to the accounts having record of receiving this product was sent on October 19, 2015.
Recalling firm
- Firm
- Synthes (USA) Products LLC
- Address
- 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986
Distribution
- Distribution pattern
- Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
Timeline
- Recall initiated
- 2015-10-19
- Posted by FDA
- 2015-11-14
- Terminated
- 2016-08-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #141160. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.