DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Reported: October 29, 2014 Initiated: October 2, 2014 #Z-0092-2015
Product Description
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Reason for Recall
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.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 11
- Distribution
- US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715. Recalled by Synthes, Inc.. Units affected: 11.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0092-2015.
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