Recall Z-0351-2020
Smith & Nephew, Inc. · initiated October 7, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A
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.
FDA-determined cause: Process control
Action taken
The firm initiated the recall by letter and email on 10/07/2019. The letter explained the issue and requested the return of the recalled product.
Details
- Recall number
- Z-0351-2020
- Initiated
- October 7, 2019
- Terminated
- March 8, 2023
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 116 devices
- Distribution
- 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.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN