Z-0122-2019 Class II Terminated
FDA device recall Z-0122-2019 was initiated by Zimmer Biomet, Inc. on Aug 8, 2018 and is designated Class II. Reason for recall: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. The recall status is terminated (terminated Jul 30, 2020). Affected quantity: 153.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 8, 2018
- Termination Date
- Jul 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153
Product Description
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Reason for Recall
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.
Code Information
Lot Numbers: 177820 177830 177890 177910 177920 244120 287770
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0122-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026