DePuy Synthes Radiolucent Retractor Recalled for Adhesive Tape Residue
Synthes, Inc. is recalling 11 DePuy Synthes Radiolucent Retractors due to adhesive tape residue that poses a risk of tissue or systemic reactions.
What this means for you
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 (anaphylaxis) in patients with latex allergy, but the source text does not report any actual illnesses or injuries, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Synthes, Inc. is recalling 11 units of the DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715. The recall was initiated because particle residue from adhesive tape used to bind the device during transport remained on the instrument.
The presence of latex particles from the adhesive tape creates a risk of tissue reaction if a patient is exposed. Additionally, patients with a latex allergy may experience a systemic reaction, such as anaphylaxis.
The affected units were distributed in the United States, including Pennsylvania, North Carolina, Tennessee, New York, Wisconsin, Washington, and Michigan. Healthcare providers should stop using the affected retractors and contact Synthes, Inc. for instructions on returning the devices.
The recalled product
- Product
- DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
- Manufacturer
- Synthes, Inc.
- Affected units
- 11
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 (2)
- Radiolucent Retractor for Upper Cervical Spine part number 387.580
- lot number 3620715.
Distribution
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