DePuy Synthes Radiolucent Retractor recall
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Why was DePuy Synthes Radiolucent Retractor 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
- Product
- DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
- Recalling firm
- Synthes, Inc.
- Quantity
- 11
- Distribution
- US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
- Recall date
- October 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)