Smith & Nephew, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0351-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 7, 2019

Date Posted: November 20, 2019

Recall Number: Z-0351-2020

Event ID: 84059

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.

Status: Terminated

Product Quantity: 116 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated