Z-0154-2019 Class II Terminated
FDA device recall Z-0154-2019 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: 16.
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
- 16
Product Description
Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 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: 679240
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0154-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026