—#140322

Product

Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K131548
Affected lot / code info: Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2015-09-21
Posted by FDA: 2015-10-15
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.