Recall Z-1352-2015
Synthes, Inc. · initiated February 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563
Reason for recall
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
FDA-determined cause: Component design/selection
Action taken
DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.
Details
- Recall number
- Z-1352-2015
- Initiated
- February 24, 2015
- Posted by FDA
- March 30, 2015
- Terminated
- September 21, 2015
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 131
- Distribution
- US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
- Recalling firm
- Synthes, Inc., West Chester, PA