Flower Orthopedics Corporation: Medical Device Recall in 2015 - (Recall #: Z-1314-2015)
See the recall detail below. You can also see other recalls from the same firm in 2015.
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
Class II
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
Voluntary: Firm initiated