Reported Jul 17, 2013 · Terminated
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
- Lot codes and dates
- The following lots of the cannulated screw driver (model
- number P/N 129733ND) were affectedD2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model
- number P/N 129735ND) were affectedD2ZQ and D3EC
- Amount recalled
- 154 screwdrivers were distributed; 67 screwdriver tips were distributed.
Where it was sold
Why it was recalled
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
This product could cause temporary or reversible health problems — stop using it.
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