—#177100

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K122170
Affected lot / code info: Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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.

Timeline

Recall initiated: 2019-10-07
Terminated: 2023-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177100. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.