Reported Nov 30, 2016 · Terminated
3.0 mm Reaming Rod/950 mm w/straight Ball 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 Reaming Rod/950 mm w/straight Ball Tip, Sterile
- Lot codes and dates
62 of 62 products
Products covered by this recall # Product as published 1 9938361 2 9970591 3 H000103 4 H001021 5 H032765 6 H032769 7 H033313 8 H043056 9 H043057 10 H043058 11 H043551 12 H043564 13 H054931 14 H054932 15 H054933 16 H056192 17 H056193 18 H056194 19 H058374 20 H058375 - Amount recalled
- 5478 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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