Z-0351-2020Class II

Lag Screw 3.2Mm Guide Pin Sleeve, Ref 71674032 -

Name: Z-0351-2020 Lag Screw 3.2Mm Guide Pin Sleeve, Ref 71674032 -
Creator: Smith & Nephew, Inc.
Published: 2019-10-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2019-10-07 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2019-10-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0351-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Posted: 2019-11-08
Terminated: 2023-03-08
Recalling firm: Smith & Nephew, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0351-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0351-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-08

Product code LXH

K122170Class IISmith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. / cleared 2012-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)