Reported Mar 14, 2018 · Terminated

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S 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 Reaming Rod, Ball tip, 950 mm, sterile
  • Part Number351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery
Lot codes and dates
  • Distributed 21-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY)
  • Expiration Date (YYYY-MM-DD)

    255 of 255 codes

    • H229232
    • 2/14/2017
    • 2026-01-31
    • H239057
    • 4/9/2017
    • 2026-02-28
    • H333939
    • 4/9/2017
    • 2026-02-28
    • H333940
    • 4/9/2017
    • 2026-02-28
    • H294380
    • 4/16/2017
    • 2026-03-31
    • H294383
    • 4/16/2017
    • 2026-03-31
    • H339342
    • 4/18/2017
    • 2026-03-31
    • H339343
    • 4/18/2017
    • 2026-03-31
    • H339349
    • 4/18/2017
    • 2026-03-31
    • H340100
    • 4/18/2017
    • 2026-03-31
    • H340112
    • 4/18/2017
    • 2026-03-31
    • H340114
    • 4/18/2017
    • 2026-03-31
    • H294387
    • 4/19/2017
    • 2026-03-31
    • H294393
    • 4/19/2017
    • 2026-03-31
    • H341135
    • 4/19/2017
    • 2026-03-31
    • H342141
    • 4/19/2017
    • 2026-03-31
    • H294373
    • 4/21/2017
    • 2026-03-31
    • H340383
    • 4/21/2017
    • 2026-03-31
    • H340912
    • 4/21/2017
    • 2026-03-31
    • H341208
    • 4/21/2017
    • 2026-03-31
Amount recalled
6257

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.

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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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, 6:50 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.