Reported Sep 7, 2022 · Ongoing
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill…
New Standard Device Inc.
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: New Standard Device Inc · 4848 Research Dr · San Antonio, TX · 78240-5005
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
620030 | Metalogix Self-Drill Half-Pin 5x40x215mm |
620040 | Metalogix Self-Drill Half-Pin 5x60x215mm |
620060 | Metalogix Self-Drill Half-Pin 5x80x215mm |
620080 | — |
- Lot codes and dates
- Part Number /
- DESCRIPTION / UDI-DI Code / Lot Numbers620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, 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
- Amount recalled
- 410 total devices
Where it was sold
Why it was recalled
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
This product could cause temporary or reversible health problems — stop using it.
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