Z-1314-2015 Class II Terminated
FDA device recall Z-1314-2015 was initiated by Flower Orthopedics Corporation on February 16, 2015 and is designated Class II. Reason for recall: Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. The recall status is terminated (terminated August 6, 2015). Affected quantity: 901.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2015
- Initiation Date
- February 16, 2015
- Termination Date
- August 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 901
Product Description
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.
Reason for Recall
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
Distribution Pattern
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
Code Information
All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126