Device product
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Z-1556-2026
Product summary
- Event
- Event 98399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1556-2026
Official wording
Reason: Augmentation devices failed bacterial endotoxin testing.
Code information: Lot: RK29976/GTIN: 00850003396248
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Derived failure modes
-
Unknown
Augmentation devices failed bacterial endotoxin testing.