Reported Mar 20, 2013 · Terminated
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to…
Synthes USA HQ, 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: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
- Lot codes and dates
- Lot Number 7542279
- Amount recalled
- 18
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
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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