Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3126-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360

Product Classification:

Class II

Date Initiated: July 17, 2018

Date Posted: September 19, 2018

Recall Number: Z-3126-2018

Event ID: 80755

Reason for Recall:

The set screw is not able to advance or reverse from the original position in the nail.

Status: Terminated

Product Quantity: 5947 total

Code Information:

107830 107850 152910 154990 482740 519610 565900 707960 762780 773410 812310 812330 097190 696380

Distribution Pattern:

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated