Darco Sterile Headed Drill BIT 4.4mm recall: Sterility Concern
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Why was Darco Sterile Headed Drill BIT 4.4mm recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
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?
Lot Number 1555781
- Product
- Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 66 units
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)