MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
This recall has been terminated (originally issued March 9, 2006).
- Company
- Orthohelix Surgical Designs Inc
- Recall Initiated
- November 1, 2005
- Posted
- March 9, 2006
- Terminated
- April 25, 2012
- Recall Number
- Z-0598-06
- Quantity
- 14
- Firm Location
- Akron, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Screwdriver pilot taper tip can break during surgery.
Distribution
Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.
Lot / Code Info
lot #11298
Root Cause
Other
Action Taken
Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.