Reported Nov 30, 2016 · Terminated
3.0 mm Guide Rod/950 mm with Smooth Tip, 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?
- 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
- Lot codes and dates
- Catalog ID 355.041S
- Lot Numbers
H085635H087271H094462H111419H136756
- Amount recalled
- 319 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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