Lower risk Medical device recall · FDA · Published May 11, 2018

Smith & Nephew Birmingham Hip Resurfacing Cups Lacking FDA Labels

Smith & Nephew recalls specific hip cup models in the US that lack required FDA labeling, potentially causing confusion during use. Affected units include sizes 54-64mm with certain reference numbers and lots.

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

🇺🇸 FDA recall #Z-2268-2018Medical device Smith & Nephew ›

Lower-risk recall

The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US

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 specific hip replacement cups that were sold in the US without proper FDA-approved labels. This could lead to confusion about how to use them safely, especially since the instructions were intended for international markets. Read more at govinfonow.com/recall/71083-smith-nephew-birmingham-hip-resurfacing-cups-lacking-fda-labels.

Source Summary by GovInfoNow · govinfonow.com/recall/71083-smith-nephew-birmingham-hip-resurfacing-cups-lacking-fda-labels · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2268-2018

Cite this page

“Smith & Nephew Birmingham Hip Resurfacing Cups Lacking FDA Labels.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71083-smith-nephew-birmingham-hip-resurfacing-cups-lacking-fda-labels. Based on FDA recall #Z-2268-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2268-2018%22&limit=1).

Smith & Nephew, Inc. recalled Birmingham Hip Resurfacing Acetabular Cups with Impactor because they lacked FDA-approved U.S. labeling, according to the Food and Drug Administration on May 11, 2018.

How to tell if you have it

Brand: Smith & Nephew
Product: Birmingham Hip Resurfacing Acetabular Cup with Impactor
Size 56 mm, REF 74120156, Lot 16CW01824
Size 64 mm, REF 74120164, Lot 16DW10975
Size 54 mm, REF 74122154, Lot 16BW17747
Size 58 mm, REF 74122158, Lot 16CW16199
Size 60 mm, REF 74122160, Lot 08GW18001B
Size 62 mm, REF 74122162, Lot 16CW20851
Distribution: OH, TX, CO, TN, MI, PA, NJ

The hazard

The devices were distributed in the U.S. with International Force Use (IFU) intended for use outside the country and did not contain the required FDA-approved labeling.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls since July 24, 2017. Other recent recalls of similar products include MicroPort HIPTURN Fem Head Trial 36mm Recalled (Dec. 19, 2025).

How to tell if you have this one

Check the product reference number (REF) and lot number on the cup. Affected models include sizes 54-64mm with specific reference numbers like 74120156, 74120164, and lots such as 16CW01824.

Brand
Smith & Nephew
Category
Medical device

FDA recall event · 2 products

All 2 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
OH, TX, CO, TN, MI, PA, NJ

Recall number	Product, codes & lots	Quantity
Z-2267-2018	Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156; (a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246	2 units
Z-2268-2018	Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162; (a) Size 56 mm, REF 74120156, Lot 16CW01824 (b) Size 64 mm, REF 74120164, Lot 16DW10975 (c) Size 54 mm, REF 74122154, Lot 16BW17747 (d) Size 58 mm, REF 74122158, Lot 16CW16199 (e) Size 60 mm, REF 74122160, Lot 08GW18001B (f) Size 62 mm, REF 74122162, Lot 16CW20851	6 units

Based on the official FDA remedy

What to do — step by step

Check Product Labels
Look for the reference number (REF) and lot number on the hip cup to determine if it's affected.

Where it went and when

Where it was distributed

Distributed in 7 states.

FDA distribution: “OH, TX, CO, TN, MI, PA, NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Michigan, New Jersey, Ohio, Pennsylvania, Tennessee, Texas.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

May 11, 2018Firm started the recall
Jun 21, 2018FDA classified it Class II
Jun 27, 2018Published in FDA’s Enforcement Report
Apr 5, 2019FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any risks to patients using these cups?

The primary risk is confusion due to missing FDA labeling, which could affect post-surgery care instructions. However, the cups themselves are designed and intended for safe use.

Similar recalls

Latest medical device recalls

Keep exploring

More Smith & Nephew recalls

Link to this recall

<a href="https://govinfonow.com/recall/71083-smith-nephew-birmingham-hip-resurfacing-cups-lacking-fda-labels">Smith &amp; Nephew Birmingham Hip Resurfacing Cups Lacking FDA Labels (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-2268-2018 (May 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2268-2018 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.