Device product
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
Z-2086-2015
Product summary
- Event
- Event 71599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100
- Official record key
device-enforcement:Z-2086-2015
Official wording
Reason: It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
Code information: Part Number 399.56 Lot Numbers T106341
Distribution pattern: US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.
Derived failure modes
-
Unknown
It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.