Z-0432-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- August 7, 2017
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 638 units
Product Description
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
Reason for Recall
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Distribution Pattern
US nationwide distribution. Also Portugal and the Netherlands.
Code Information
Item No. 814611280; Lot No. (Exp. Date) UDI: 459270 (05/18/2027) UDI (01)00887868039775 (17)270518 (10)459270; 858780 (06/16/2027) UDI (01)00887868039775 (17)270616 (10)858780; 972840 (06/15/2027) UDI (01)00887868039775 (17)270615 (10)972840