Z-3055-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
September 19, 2018
Initiation Date
July 17, 2018
Termination Date
June 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5947 total

Product Description

Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

Reason for Recall

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

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.

Code Information

017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330 153470 153490 153510 153540 219770 219780 290570 290580 290620 500680 500710 500740 503300 503350 519650 565790 565800 585690 601380 628190 645550 645580 688170 688190 688200 688210 707670 741680 741690 741700 899820 899840 899850 899870 899880 900000