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Recall Observatory FDA recall evidence

Device product

Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures

Z-0151-2019

August 08, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 81038
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0151-2019

Official wording

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

Code information: Lot Numbers: 679160

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging was already open