—#147065

Product

3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K021932
Affected lot / code info: Many affected part numbers

Why it was recalled

Labeling does not match the cleared indications for use in the United States and Canada.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Timeline

Recall initiated: 2016-02-16
Posted by FDA: 2016-07-11
Terminated: 2017-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147065. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.