Device product
Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
Z-0150-2019
Product summary
- Event
- Event 81038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33
- Official record key
device-enforcement:Z-0150-2019
Official wording
Reason: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Code information: Lot Numbers: 244270 679300
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.
Derived failure modes
-
Sterility assurance
sterile packaging was already open