Metalogix Self-Drill Half-Pin Surgical Component Recalled for Tip Breakage
New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.
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: FDA Class II device with risk-of-harm from tip breakage during surgical use. No hospitalizations or injuries have been reported in the source material, but the hazard presents serious risk during active surgical procedures.
Plain-English summary
New Standard Device Inc is recalling the Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System used in orthopedic surgery. The recall affects four part numbers (5x30x215mm, 5x40x215mm, 5x60x215mm, and 5x80x215mm) distributed across multiple lot numbers.
Complaints were received reporting that the self-drill half-pin tips break during surgical procedures. A tip breakage occurring during surgery could compromise the fixation system's function and affect surgical outcomes.
The affected devices were distributed in the United States across Arizona, Georgia, Illinois, Montana, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, Texas, and Virginia. A total of 410 devices are involved in this recall.
Healthcare facilities that have received these devices should cease use immediately and contact New Standard Device Inc for instructions on device return and replacement.
The recalled product
- Product
- Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metal
- Manufacturer
- New Standard Device Inc
- Affected units
- 410
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 (4)
- A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y
- A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z
- A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A
- A17219CD
Distribution
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