Reported Mar 14, 2018 · Terminated
2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for…
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, Ball tip with extension, 950 mm, sterile
- Part Number351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery
- Lot codes and dates
- Distributed 17-Apr-2017 to 8-June-2017; Lot Number Manufacturing Date (M/D/YYYY)
- Expiration Date (YYYY-MM-DD)
H0405017/29/20162025-06-30H1054988/5/20162026-02-28H21382410/27/20162025-09-30
- Amount recalled
- 216
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
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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