Device product
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Z-1364-2018
Product summary
- Firm
- Orthofix, Inc
- Event
- Event 79498
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188 units
- Official record key
device-enforcement:Z-1364-2018
Official wording
Reason: 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.
Code information: UDI 18257200125364, Lot Numbers: O01 and O02
Distribution pattern: US
Derived failure modes
-
Unknown
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.