Z-0453-2019 Class II Terminated
FDA device recall Z-0453-2019 was initiated by Zimmer Biomet, Inc. on Oct 2, 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: 2,163 in total (expanded).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Oct 2, 2018
- Termination Date
- Jun 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,163 in total (expanded)
Product Description
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Reason for Recall
The set screw is not able to advance or reverse from the original position in the nail.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.
Code Information
Lot number 558260 558270
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0453-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026