medical Class II Updated 2019-11-20

Smith & Nephew, Inc. recalls LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usa

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A
View official government recall

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