Lower risk Medical device recall · FDA · Published March 30, 2018

Smith & Nephew Legion CR XLPE Articular Insert Recall: Packaging Issue

Smith & Nephew recalls specific articular inserts due to improper packaging that may cause injury during surgery. Affected products include batch numbers 11DM11664 and 15BM09445.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1906-2018Medical device Smith & Nephew ›

Lower-risk recall

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Take action

Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804

✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling certain articular inserts for surgery use because they were packaged incorrectly. This packaging issue could lead to injury during procedures if the inner pouch isn't properly separated from the outer pouch. Read more at govinfonow.com/recall/71564-smith-nephew-legion-cr-xlpe-articular-insert-recall-packaging-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/71564-smith-nephew-legion-cr-xlpe-articular-insert-recall-packaging-issue · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1906-2018

Cite this page

“Smith & Nephew Legion CR XLPE Articular Insert Recall: Packaging Issue.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71564-smith-nephew-legion-cr-xlpe-articular-insert-recall-packaging-issue. Based on FDA recall #Z-1906-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2018%22&limit=1).

Smith & Nephew, Inc. voluntarily recalled specific smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Inserts on March 30, 2018, according to the Food and Drug Administration (FDA). The products were inadvertently packaged with the inner pouch sealed to the outer pouch.

How to tell if you have it

Brand: Smith & Nephew
Product: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM
REF: 71453121
Batch Numbers: 11DM11664 & 15BM09445

The hazard

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Context

GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Recent brand recalls include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026) and the Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025). Other recent recalls of similar products include the Henry Schein Structur 2 SC Resin Cartridge Refills with Incorrect Packaging (July 9, 2026), the Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE packaging mix-up (Feb. 16, 2026), and the Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM discrepancy risk (Jan. 5, 2026).

How to tell if you have this one

Check for batch numbers 11DM11664 or 15BM09445 on the product label. The product is a Smith & Nephew Legion CR XLPE High Lexion Articular Insert, size 5-6, 9 mm.

Brand
Smith & Nephew
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore

Recall number	Product, codes & lots	Quantity
Z-1904-2018	smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.; Batch Number 16EM12620	16 units
Z-1905-2018	smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.; Batch Numbers: 09FM04561; 14AM05774 & 15GM11501	72 units
Z-1906-2018	smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.; Batch Numbers: 11DM11664 & 15BM09445	N/A
Z-1907-2018	smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.; Batch Numbers: 08BM09288; 12EM05884 & 12EM07720	47 units

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for batch numbers 11DM11664 or 15BM09445 on the product label.

How this recall unfolded

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Mar 30, 2018Firm started the recall
May 22, 2018FDA classified it Class II
May 30, 2018Published in FDA’s Enforcement Report
Aug 21, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71564-smith-nephew-legion-cr-xlpe-articular-insert-recall-packaging-issue">Smith &amp; Nephew Legion CR XLPE Articular Insert Recall: Packaging Issue (GovInfoNow)</a>

Where this comes from

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-1906-2018 (March 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1906-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.