Synthes Malleable C-Retractor Recalled Due to Potential Spring Corrosion
Synthes, Inc. is recalling Malleable C-Retractors because the internal spring may corrode or fail, potentially transferring particles to patients and causing adverse tissue reactions or infection.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (potential infection and adverse tissue reaction) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Synthes, Inc. is recalling 1,762 units of the Malleable C-Retractor (Part Number 397.232). This medical device is used to retract soft tissues during surgical procedures involving trocar instrumentation and is compatible with several craniofacial and orthognathic plating systems. The recall covers units distributed nationwide in the United States and internationally to Canada.
The recall was initiated because the internal spring of the retractor may have been manufactured from an incorrect material, leading to potential failure and/or corrosion. If the spring fails, particles could transfer from the instrument to the patient, which may lead to an adverse tissue reaction and/or infection. Additionally, the failure of the instrument may cause surgical delays.
Healthcare providers and facilities that have received these devices should stop using them and contact Synthes, Inc. for further instructions on return or replacement. Patients who have had surgery using these devices should consult their healthcare provider if they experience any unusual symptoms or concerns related to the surgical site.
The recalled product
- 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)…
- Manufacturer
- Synthes, Inc.
- Affected units
- 1,762
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 397.232
Distribution
Distributed nationwide across the United States.
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