Z-0380-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- July 31, 2013
- Termination Date
- August 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98
Product Description
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.
Reason for Recall
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.
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.
Code Information
Lot 3420620