Reported Nov 30, 2016 · Terminated
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Synthes (USA) Products 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: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
- Lot codes and dates
- Catalog ID 355.042S
- Lot Numbers
H085634H094463
- Amount recalled
- 139 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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