Lower riskMedical device recall · FDA · Published October 7, 2019
Smith & Nephew LAG Screw 3.2mm Guide Pin Sleeve Recall: Manufacturing Error Risk
Smith & Nephew recalls LAG screw 3.2mm guide pin sleeves (ref 71674032) due to manufacturing error causing detent balls to not fully compress. Affected batch numbers include 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A.
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.
Smith & Nephew is recalling LAG screw 3.2mm guide pin sleeves (ref 71674032) because a manufacturing error means the detent balls won't fully compress. This could lead to improper nail fixation during fracture treatment, potentially causing complications in orthopedic procedures. Read more at govinfonow.com/recall/66878-smith-nephew-lag-screw-3-2mm-guide-pin-sleeve-recall.
“Smith & Nephew LAG Screw 3.2mm Guide Pin Sleeve Recall: Manufacturing Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66878-smith-nephew-lag-screw-3-2mm-guide-pin-sleeve-recall. Based on FDA recall #Z-0351-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0351-2020%22&limit=1).
Smith & Nephew, Inc. voluntarily recalled LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032, due to a manufacturing error causing detent balls to not fully compress, the FDA said on Oct. 7, 2019.
How to tell if you have it
Brand: Smith & Nephew
Product: LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032
The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress, according to the FDA.
Context
GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW (Feb. 25, 2026), Charlotte Claw Screw (Aug. 18, 2026), and Acumed Hexalob Screw (May 28, 2026).
How to tell if you have this one
Check for the product name 'LAG SCREW 3.2MM GUIDE PIN SLEEVE' with reference number 71674032. Affected batch numbers are 18DM11613A, 18HM02575, 18HM13327A, and 18HM20956A.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Batch
Identify the batch number on the product label to determine if it matches the affected batches: 18DM11613A, 18HM02575, 18HM13327A, or 18HM20956A.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Which medical procedures use the recalled product?
The TRIGEN InterTAN nails are used for femur fractures including simple shaft fractures, comminuted shaft fractures, and other specific fracture types.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0351-2020 (October 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0351-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.