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.
This recall has been terminated (originally issued March 24, 2015).
- Company
- Flower Orthopedics Corporation
- Recall Initiated
- February 16, 2015
- Posted
- March 24, 2015
- Terminated
- August 6, 2015
- Recall Number
- Z-1314-2015
- Quantity
- 901
- Firm Location
- Horsham, PA
- Official Source
- View on FDA website ↗
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
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
Lot / Code Info
All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
Root Cause
Device Design
Action Taken
On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.