Reported Oct 29, 2014 · Terminated
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
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?
DePuy Synthes Radiolucent Retractorpart number 387.580lot number 3620715
- Lot codes and dates
- Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
- Amount recalled
- 11
Where it was sold
Why it was recalled
Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
This product could cause temporary or reversible health problems — stop using it.
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