Recall Z-0973-2015— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2014-12-15, terminated 2016-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.. Reason: Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-15
- Terminated
- 2016-08-18
- Firm location
- West Chester, PA, United States
Product description
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
Reason for recall
Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.
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