Z-0351-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 7, 2019
- Termination Date
- March 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116 devices
Product Description
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.
Reason for Recall
LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
Distribution Pattern
Worldwide distributions - US Nationwide distributions and countries of Belgium, Brazil, China, Columbia, France, Great Britain, India, Japan, Russia, Singapore, South Africa, Spain,and United Arab Emirates.
Code Information
Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A