Recall Z-0351-2020 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew, Inc.
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;
| Date | Oct 7, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122170 | SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION Smith & Nephew, Inc., Oct 19, 2012 |