Flower Orthopedics Recalls Variable Angle Locking Pegs Due to Failure
Flower Orthopedics is recalling 901 Variable Angle Locking Pegs because they failed to lock during distal radius procedures, resulting in one scheduled revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure of a medical device that resulted in a scheduled revision surgery, fitting the criteria for a risk-of-harm product where injury has not yet been reported as a completed adverse event.
Plain-English summary
Flower Orthopedics Corporation is recalling 901 units of Variable Angle Locking Pegs in various sizes (1.8mm diameter, 14.0mm to 26.0mm length). These medical devices are intended to be used with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone. The affected catalog numbers are FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, and FLP 126.
The recall was initiated because the locking pegs were not locking during distal radius procedures. The company has received one report of a revision surgery scheduled to remove a loosened peg. The devices were distributed in the states of Virginia, Texas, Illinois, Oklahoma, Pennsylvania, California, New York, Kentucky, and Florida.
Healthcare providers and patients should stop using these specific locking pegs. Patients who have had these devices implanted should contact their healthcare provider to discuss the potential need for revision surgery if the peg is not securely locked.
The recalled product
- Product
- 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…
- Manufacturer
- Flower Orthopedics Corporation
- Affected units
- 901
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- All lots of Catalog Numbers: FLP 114
- FLP 116
- FLP 118
- FLP 120
- FLP 122
- FLP 124
- FLP 126
Distribution
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