Device product
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.
Z-0351-2020
Product summary
- Event
- Event 84059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 116 devices
- Official record key
device-enforcement:Z-0351-2020
Official wording
Reason: 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.
Code information: Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A
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.
Derived failure modes
-
Manufacturing or process control
manufacturing error