Recall Z-0092-2015— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2014-10-02, terminated 2015-12-18. FDA's recall record names no specific 510(k) clearance for this event. Product: DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715. Reason: 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..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-02
- Terminated
- 2015-12-18
- Firm location
- West Chester, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.