Reported Feb 21, 2018 · Terminated
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
OrthoPediatrics Corp.
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: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- Response 5.5/6.0 Spine System 7.0mm
- x 40mm Pedicle Screw Product UsagePosterior non-cervical pedicle screw fixation
- Lot codes and dates
- Model number00-1300-0740
- Lot numberM82791-1
- Amount recalled
- 24 units
Where it was sold
- Nationwide
Why it was recalled
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
This product could cause temporary or reversible health problems — stop using it.
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