Reported Nov 30, 2016 · Terminated
2.5 mm Reaming Rod W/Ball Tip 650 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 Reaming Rod W/Ball Tip 650 mm, Sterile
- Lot codes and dates
62 of 62 products
Products covered by this recall # Product as published 1 9913251 2 9913252 3 9913254 4 9913256 5 9913259 6 9913260 7 9950460 8 9950461 9 9950462 10 9950463 11 9950464 12 9963747 13 9963748 14 9963749 15 9963751 16 9963752 17 9963753 18 9963755 19 9963756 20 9963757 - Amount recalled
- 2,157 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.
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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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