Reported Oct 14, 2015 · Terminated

Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP…

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?

  • Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Lot codes and dates
  • Part Numbers03.120.005 03.120.004 03.120.002 03.120.001
  • with Lot Numbers
    • 1780076
    • 1797331
    • 1829300 1789754
    • 1802319
    • 1810706
    • 1810707
    • 5704446 1780074
    • 1829294
    • 1829296 1789751
    • 1802318
    • 1810704
    • 1810705
    • 1828749
    • 1879604
Amount recalled
172

Why it was recalled

Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 15, 2016 · Data as of Sep 19, 6:46 PM UTC

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