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Recall Observatory FDA recall evidence

Device product

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360

Z-3157-2018

July 17, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80755
Status
Terminated
Classification
Class II
Quantity
5947 total
Official record key
device-enforcement:Z-3157-2018

Official wording

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

Code information: 017730 085400 154660 154670 154680 157450 558510 565960 694270 711210 812570 812730 818350 945040 629800

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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