Reported Mar 14, 2018 · Terminated

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers…

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 Titanium Calibrated Reaming Rod
    • 850 mm
  • Part Number359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery
Lot codes and dates
  • Distributed 12-May-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY)
  • Expiration Date (YYYY-MM-DD)H270855 5/12/2017 2026-04-30
Amount recalled
63

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 10, 2018 · Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.