Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0157-2019)

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 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures

Product Classification:

Class II

Date Initiated: August 8, 2018

Date Posted: October 24, 2018

Recall Number: Z-0157-2019

Event ID: 81038

Reason for Recall:

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Status: Terminated

Product Quantity: 22

Code Information:

Lot Numbers: 201440

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated