Z-3055-2018 Class II Terminated
FDA device recall Z-3055-2018 was initiated by Zimmer Biomet, Inc. on Jul 17, 2018 and is designated Class II. Reason for recall: The set screw is not able to advance or reverse from the original position in the nail. The recall status is terminated (terminated Jun 2, 2020). Affected quantity: 5947 total.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2018
- Initiation Date
- Jul 17, 2018
- Termination Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3055-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026