The Recall Desk
HighFDA (Devices)·Z-1799-2015·Announced 2015-06-24

Synthes Pull Reduction Device Recalled for Potential Intraoperative Breakage

Synthes, Inc. is recalling Pull Reduction Devices for 4.3mm Percutaneous Drill Guides because incorrect hardness specifications may cause the devices to break during surgery.

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 is classified as FDA Class II, and the hazard involves a risk of harm (intraoperative breakage) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Synthes, Inc. is recalling certain lots of the Pull Reduction Device for 4.3mm Percutaneous Drill Guide. The device is a medical instrument used to pull or push bone fragments relative to a plate during orthopedic procedures, including minor varus-valgus adjustments and stabilization of plate bone orientation.

The recall is being conducted because certain affected parts and lots may have been manufactured to an incorrect hardness specification. This defect could result in the device breaking intraoperatively, or during the surgical procedure.

The recall involves 3,747 units in the United States and 19 units in foreign markets. The affected products were distributed nationwide in the US and internationally to Canada. The specific part number is 03.120.023, and the recall covers a specific list of lot numbers provided in the agency's official documentation.

The recalled product

Product
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approx
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Instrument
Hazard

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 (1)

  • Part Number: 03.120.023

Distribution

Distributed nationwide across the United States.

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