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Smith & Nephew, Inc. recalls LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of
Recalled November 20, 2019 · FDA recall Z-0351-2020 · Smith & Nephew
Hazard
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. · FDA Class II
Units
116 devices
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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.
Description
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.
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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →