Integra Hallu-Fix cannulated screw driver recall
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in…
Why was Integra Hallu-Fix cannulated screw driver recalled?
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
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?
The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.
- Product
- Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 154 screwdrivers were distributed; 67 screwdriver tips were distributed.
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)