Synthes, Inc. 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Synthes, Inc.
Lot Codes / Batch Numbers
Part Number 397.232
Products Sold
Part Number 397.232, Lot Numbers 1698700 4688882 4868698 5129449 5345722 6009689 6235842 6407718 1702300 4688883 4916060 5129450 5356127 6021041 6241331 6407719 1715800 4772507 4916061 5129453 5382066 6023019 6258401 6446480 175220 4772508 4916062 5247085 5422622 6023020 6258402 6446481 1685602 4814278 4991953 5247087 5664372 6040195 6300954 6452871 1695100 4814280 4991962 5263641 5664373 6040196 6321761 6452872 1695101 4814281 4992455 5267067 5685461 6056610 6345256 6623687 1706600 4868678 5032047 5267068 5820702 6097962 6345257 6633304 1776300 4868685 5080386 5287150 5839165 6181398 6355110 1798900 4868691 5080387 5287152 5855648 6212655 6407717
Synthes, Inc. is recalling Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during u due to Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical del. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026