The Recall Desk
HighFDA (Devices)·Z-1174-2014·Announced 2014-03-19

Synthes Small Notch Titanium Reconstructive Plate Recalled for Contraindicated Spine Use

Synthes, Inc. is recalling Small Notch Titanium Reconstructive Plate sets distributed for spine applications where they are contraindicated.

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 medical device used for bone fixation that was distributed for contraindicated applications. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Synthes, Inc. is recalling the Synthes Small Notch Titanium Reconstructive Plate set. The recall involves 18,747 units distributed nationwide in the United States. The product is a medical device used for fixation to allow bone fusion.

The recall was initiated because certain modules containing the plate set were distributed by Spine sales consultants for spine applications, despite being contraindicated for such use. The source text does not specify the exact nature of the contraindication or report any specific injuries or illnesses associated with the use of these devices.

Healthcare providers and patients who have received these specific plate sets should contact Synthes, Inc. for further instructions. The recall covers all lots of parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425.

The recalled product

Product
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants a
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
18,747

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 (10)

  • All lots of Parts 489.401
  • 489.402
  • 489.412
  • 489.413
  • 489.414
  • 489.415
  • 489.418
  • 489.423
  • 489.424
  • and 489.425.

Distribution

Distributed nationwide across the United States.

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Same hazard · contraindicated use

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