Device product
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Z-0380-2014
Product summary
- Event
- Event 66411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98
- Official record key
device-enforcement:Z-0380-2014
Official wording
Reason: Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.
Code information: Lot 3420620
Distribution pattern: Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
Derived failure modes
-
Labeling or packaging
mislabeling