Reported Jan 21, 2015 · Terminated
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar…
Synthes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation
- Used in the following systemsthe Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System
- Lot codes and dates
- Part Number 397.232, Lot Numbers
78 of 78 codes
16987004688882486869851294495345722600968962358426407718170230046888834916060512945053561276021041624133164077191715800477250749160615129453538206660230196258401644648017522047725084916062524708554226226023020625840264464811685602481427849919535247087566437260401956300954645287116951004814280499196252636415664373604019663217616452872169510148142814992455526706756854616056610634525666236871706600486867850320475267068
- Part Number 397.232, Lot Numbers
- Amount recalled
- 1762
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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