Z-0351-2020 Class II Terminated
FDA device recall Z-0351-2020 was initiated by Smith & Nephew, Inc. on October 7, 2019 and is designated Class II. 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 compr… The recall status is terminated (terminated March 8, 2023). Affected quantity: 116 devices.
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