Orthalign knee drill plates may allow a bone cut exceeding specification
Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.
What this means for you
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an out-of-specification drill plate can guide a bone cut beyond the intended depth, and no injuries are stated in the source.
Plain-English summary
Orthalign, Inc is recalling the Drill Plate, Ortho Dev. Trimax - Pegged, PREF size 6-7, REF 402567, a component of the Lantern Knee System. About 7 units were distributed in Utah. The FDA has classified this recall as Class II.
Drill plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches (2.8448 mm).
Affected product is lot 25092204BB, carrying UDI 00810832032434.
Facilities can identify affected plates by the REF, lot and UDI above, and may contact Orthalign, Inc for further information.
The recalled product
- Product
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
- Manufacturer
- Orthalign, Inc
- Hazard
- out-of-specification
- excess-bone-cut
- surgical-risk
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 (1)
- Lot # 25092204BB/ UDI:00810832032434
Distribution
Distributed nationwide across the United States.
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