Reported Apr 1, 2015 · Terminated
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…
Flower Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flower Orthopedics Corporation · 100 Witmer Rd Ste 280 · Horsham, PA · 19044-2647
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Variable Angle Locking Peg, D:1.8mm x L:14.0mm |
| 2 | Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm |
| 3 | Variable Angle Locking Peg, D:1.8mm x L:20.0mm |
| 4 | Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm |
| 5 | 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. |
- Lot codes and dates
- All lots of Catalog Numbers
FLP 114FLP 116FLP 118FLP 120FLP 122FLP 124FLP 126
- All lots of Catalog Numbers
- Amount recalled
- 901
Where it was sold
Why it was recalled
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
This product could cause temporary or reversible health problems — stop using it.
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