Z-1363-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- June 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 397 units
Product Description
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Reason for Recall
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
Distribution Pattern
US
Code Information
UDI 18257200125371, Lot Numbers: O02, O03 and O04