Z-1352-2015 Class II Terminated
FDA device recall Z-1352-2015 was initiated by Synthes, Inc. on February 24, 2015 and is designated Class II. Reason for recall: The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. The recall status is terminated (terminated September 21, 2015). Affected quantity: 131.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- February 24, 2015
- Termination Date
- September 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 131
Product Description
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Reason for Recall
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Distribution Pattern
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Code Information
Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563