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Recall Observatory FDA recall evidence

Device product

Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180

Z-3120-2018

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-3120-2018

Official wording

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

Code information: 072620 130760 130770 130780 130790 130800 130810 130820 130840 130850 130860 130900 130920 131030 156770 157000 188340 219800 219810 219820 219910 245570 245690 287090 287120 287130 371170 456160 519490 530110 530120 530130 558980 565870 565880 601390 707920 768050 772730 854270 901300 901330 901350 901360 901370 901380 901400 901410 944660 944720 970790 970810 970820 970830 970840 970850 970860 970870 970880 970890 130930 130940 156970 503980 503990 504000 504010

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.