Integra Recalls Malibu Polyaxial Screwdrivers Due to Potential Shaft Breakage
Integra LifeSciences is recalling 40 Malibu Polyaxial Screwdrivers because the shaft may break during use. No patient injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling 40 units of the Malibu Polyaxial Screwdriver, Model Numbers 91-2109 (8.0 Plus) and 91-2110 (Standard). The recall was initiated after an investigation of complaints identified a potential for the shaft of the drivers to break during use.
The affected devices are surgical instruments intended for use with the Malibu System, which is used for posterior, non-cervical spinal implants. The devices were distributed worldwide, including in the United States and South Africa. The specific lots involved are AL549784F, AL552404F, and AL546768F.
No patient injuries were reported in the complaints that triggered the recall. However, some complaints indicated that surgeries were slightly prolonged while additional drivers provided in the kits were retrieved and used. Healthcare facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical impl
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 40
Distribution
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