Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text reports that the device tips broke during surgery, which constitutes a significant injury risk during a medical procedure.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). These medical devices are indicated for use in the fixation of fractures, osteotomies, and arthrodesis of the first metatarso-phalangeal joint.
The recall was initiated after the firm received numerous complaints that the cannulated screw driver tip broke during surgery. A total of 154 screwdrivers and 67 screwdriver tips were distributed. The affected lots for the screw driver are D2ZG, D32L, D3HV, D3PG, and E0U3, while the affected lots for the screwdriver tip are D2ZQ and D3EC.
The products were distributed nationwide in the United States and in numerous countries worldwide, including Canada, Austria, Belgium, Switzerland, and the United Kingdom. Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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 fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
- Manufacturer
- Integra LifeSciences Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- D32L
- D3HV
Distribution
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