Device product
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, 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.
Z-2153-2016
Product summary
- Event
- Event 74283
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,497,844 units in total
- Official record key
device-enforcement:Z-2153-2016
Official wording
Reason: Labeling does not match the cleared indications for use in the United States and Canada.
Code information: Many affected part numbers
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.
Derived failure modes
-
Unknown
Labeling does not match the cleared indications for use in the United States and Canada.