The Recall Desk
HighFDA (Devices)·Z-0907-2018·Announced 2018-03-14

Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility

Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic 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 involves a medical device with a potential lack of sterility, which constitutes a high-risk pathogen exposure scenario. Although no illnesses have been reported, the risk of harm is significant enough to warrant a Class II classification.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling a specific lot of the Light Clip for Oracle Retractor, sterile, Part Number 03.809.925S. This recall affects six units distributed nationwide in the United States and in Canada between April 21, 2017, and May 12, 2017.

The reaming rods included with this product are intended for guiding reamers during orthopedic surgery. The recall is being initiated because there is a possible lack of product sterility due to potential gaps or channeling in the seal of the package. Compromised sterility poses a risk of infection if the device is used on patients.

Consumers who possess this product should stop using it immediately and contact Synthes (USA) Products LLC for further instructions regarding return or replacement.

The recalled product

Product
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
6

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)

  • Distributed 21-Apr-2017 to 12-May-2017

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Synthes (USA) Products LLC

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Same hazard · lack of sterility

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