Z-3168-2018 Class II Terminated
FDA device recall Z-3168-2018 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 Left 130¿ 13 mm x 360 mm, Item Number: 814613360
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
816070 091850
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3168-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026