Reported Mar 14, 2018 · Terminated

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S 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, 1150 mm, sterile
  • Part Number351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery
Lot codes and dates
  • Distributed 10-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY)
  • Expiration Date (YYYY-MM-DD)
    • H311894
    • 3/9/2017
    • 2026-01-31
    • H311912
    • 3/9/2017
    • 2026-01-31
    • H311913
    • 3/9/2017
    • 2026-01-31
    • H311941
    • 3/9/2017
    • 2026-01-31
    • H311942
    • 3/9/2017
    • 2026-01-31
    • H311925
    • 3/14/2017
    • 2026-01-31
    • H311938
    • 3/14/2017
    • 2026-01-31
    • H311924
    • 4/9/2017
    • 2026-01-31
    • H334430
    • 4/13/2017
    • 2026-02-28
    • H334555
    • 4/13/2017
    • 2026-02-28
    • H334556
    • 4/19/2017
    • 2026-02-28
    • H336080
    • 4/19/2017
    • 2026-03-31
    • H336081
    • 4/19/2017
    • 2026-03-31
    • H336083
    • 4/19/2017
    • 2026-03-31
    • H317169
    • 5/10/2017
    • 2026-03-31
    • H317170
    • 5/10/2017
    • 2026-03-31
Amount recalled
1144

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?

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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.