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Lower risk Medical device recall · FDA · Published April 20, 2021

Signature Orthopedics Logical Cup Liner Recalled Due to Mislabeled Product

Signature Orthopedics recalls Logical cup liners due to incorrect product being shipped. Consumers should check lot numbers for affected items.

🇺🇸 FDA recall #Z-1694-2021Medical deviceSignature Orthopedics ›
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Recalling firmSignature Orthopedics Pty LimitedLane Cove W, 7 Sirius Rd · Lane Cove West, Australia
✎ GovInfoNow plain-language explainer

Signature Orthoped: Logical cup liners are recalled because they were shipped with the wrong product inside the package. This mislabeling means the product may not function as intended for hip joint replacements. Read more at govinfonow.com/recall/62764-signature-orthopedics-logical-cup-liner-recalled-due-to-mislabeled-product.

Source Summary by GovInfoNow · govinfonow.com/recall/62764-signature-orthopedics-logical-cup-liner-recalled-due-to-mislabeled-product · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1694-2021

Cite this page

“Signature Orthopedics Logical Cup Liner Recalled Due to Mislabeled Product.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62764-signature-orthopedics-logical-cup-liner-recalled-due-to-mislabeled-product. Based on FDA recall #Z-1694-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1694-2021%22&limit=1).

The FDA announced on April 20, 2021, that Signature Orthopedics Pty Limited is recalling its Logical cup liner due to product mislabeling. The hazard involves receiving the incorrect product inside the package. This Class II recall affects three units distributed nationwide in North Carolina.

How to tell if you have it

  • Brand: Signature Orthopedics
  • Product: Logical cup liner
  • Lot code: LOT# 71541-1
  • Quantity: 3 units

The hazard

The logical cup liners were mislabeled, resulting in the incorrect product being packaged inside. This error poses a risk of surgical complications if the wrong implant is used.

Context

GovInfoNow's records show Signature Orthopedics Pty Limited has issued two other recalls since February 2, 2018, including a December 10, 2018, recall for Genius Knee Cemented CR Femoral Components due to product mix-up hazards and a February 2, 2018, recall for Signature Ceramic Femoral Heads caused by mislabeling. Other recent recalls of similar products include the EMPOWR 3D KNEE Implants with incorrect labeling (January 15, 2026), the Encore Medical EMPOWR Acetabular System packaging discrepancy (January 5, 2026), and the Orthof Minirail Fixator M122 labeled incorrectly (June 10, 2026).

How to tell if you have this one

Check the lot number on the package. Affected items have the lot number 71541-1.

  • Brand
    Signature Orthopedics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Package Lot Number

    Look for the lot number 71541-1 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Apr 20, 202112. FDA classified it Class II: May 28, 202123. Published in FDA’s Enforcement Report: Jun 9, 202134. FDA terminated the recall: Jan 19, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this product?

The recall is due to mislabeling, not a direct safety hazard. However, using the wrong product could affect the hip joint replacement.

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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-1694-2021 (April 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1694-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA