Reported Nov 11, 2015 · Terminated
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate…
Biomet Spine, LLC
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: Biomet Spine, LLC · 310 Interlocken Pkwy Ste 120 · Broomfield, CO · 80021-3464
Is this the product you have?
- MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
- Lot codes and dates
- P/N14-521550
- Lot Numbers463870
- P/N14-521548
- Lot NumbersJ86056
- P/N14-521518
- Lot NumbersJ26394
- Model Numbers14-521518 14-521520 14-521548 14-521550
- Amount recalled
- 17 units
Where it was sold
Why it was recalled
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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