Z-0380-2014 Class II Terminated
FDA device recall Z-0380-2014 was initiated by Synthes USA HQ, Inc. on Jul 31, 2013 and is designated Class II. 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. The recall status is terminated (terminated Aug 18, 2016). Affected quantity: 98.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 31, 2013
- Termination Date
- Aug 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