The Recall Desk
HighFDA (Devices)·Z-1238-2013·Announced 2013-05-15

Synthes Radial Head Prosthesis Recalled Due to Potential Component Separation

Synthes USA is recalling 417 trial radial head prostheses because the trial head may come loose from the implant stem during surgery. No adverse events have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is theoretical and the source explicitly states that no injuries or adverse events have been reported, which aligns with the High severity criteria.

Plain-English summary

Synthes USA HQ, Inc. is recalling 417 units of the Synthes Radial Head Prosthesis: Trial Radial Head. This medical device is a two-piece modular system used for elbow joint replacement, consisting of a titanium alloy stem and cobalt chrome components. The recall covers all lots of specific part numbers listed in the agency documentation.

The recall was initiated because the trial head may come loose from the implant stem during manipulation of the arm during surgery. The source text explicitly states that no adverse events have been reported related to this issue and that the recall is not being initiated as a result of adverse events.

The affected devices were distributed nationwide in the United States, including in Illinois, Indiana, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, and Wisconsin. Healthcare providers and patients should contact Synthes USA HQ, Inc. for further instructions regarding the return or replacement of these specific trial components.

The recalled product

Product
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ asse
Manufacturer
Synthes USA HQ, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
417

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All Lots of Part Numbers: 03.402.018
  • 03.402.020
  • 03.402.022
  • 03.402.024
  • 03.402.026
  • 03.402.028
  • 03.402.218
  • 03.402.220
  • 03.402.222
  • 03.402.224
  • 03.402.226
  • 03.402.228
  • 03.402.418
  • 03.402.420
  • 03.402.422
  • 03.402.424
  • 03.402.426
  • 03.402.428
  • 03.402.618
  • 03.402.620

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Related recalls

Same manufacturer · Synthes USA HQ, Inc.

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Same hazard · component separation

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