Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-2158-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 16, 2016

Date Posted: July 20, 2016

Recall Number: Z-2158-2016

Event ID: 74283

Reason for Recall:

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

Status: Terminated

Product Quantity: 19,497,844 units in total

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.

Voluntary or Mandated:

Voluntary: Firm initiated