Skip to content
Lower risk Medical device recall · FDA · Published August 21, 2019

Zimmer Sidus Shoulder Implant Has Incorrect Labeling - Recall

Zimmer recalls Sidus Stem-Free Shoulder Humeral Head 50-18 implants due to incorrect labeling showing size 50-18 when actual size is 40-14. This mismatch could lead to improper surgical fitting.

🇺🇸 FDA recall #Z-2762-2019Medical deviceZimmer ›
Take action

Contact the company

Recalling firmZimmer GmbHSulzerallee 8 · Winterthur, Switzerland
✎ GovInfoNow plain-language explainer

Zimmer is recalling Sidus Stem-Free Shoulder Humeral Head implants because the packaging labels show size 50-18 but the actual implants are size 40-14. This mismatch could cause improper surgical fitting if used without correction. Read more at govinfonow.com/recall/67138-zimmer-sidus-shoulder-implant-has-incorrect-labeling-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/67138-zimmer-sidus-shoulder-implant-has-incorrect-labeling-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2762-2019

Cite this page

“Zimmer Sidus Shoulder Implant Has Incorrect Labeling - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67138-zimmer-sidus-shoulder-implant-has-incorrect-labeling-recall. Based on FDA recall #Z-2762-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2762-2019%22&limit=1).

The FDA announced on Aug. 21, 2019, that Zimmer GmbH voluntarily recalled Sidus Stem-Free Shoulder Humeral Head implants due to incorrect labeling. The package label shows size 50-18 while the implant inside is size 40-14.

How to tell if you have it

  • Brand: Zimmer
  • Product: Sidus Stem-Free Shoulder Humeral Head 50-18
  • Item number: 01.04555.500
  • Lot #: 2941696
  • UPC: 00889024415973

The hazard

The hazard is incorrect labeling on the product package. The label displays size 50-18, but the implant inside is size 40-14.

Context

GovInfoNow's records show Zimmer GmbH has six other recalls since Feb. 28, 2018, including a mislabeled neck sleeve risk on Aug. 8, 2024, and a potential commingle issue with the Natural Nail System on May 7, 2021. Other recent recalls of similar products include the Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026) and Grace Medical's Stapes Prosthesis recall (April 3, 2026).

How to tell if you have this one

Look for the Sidus Stem-Free Shoulder Humeral Head 50-18 implant with item number 01.04555.500. The lot number 2941696 and UDI (01) 00889024415973 are also associated with this recall.

  • Brand
    Zimmer
  • Product
    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Label

    Verify the implant size on the packaging against the actual implant size to ensure it matches the correct size 40-14.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Colorado, Kansas, New Jersey, New York, Ohio, Oklahoma.

Recall timeline

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

1. Firm started the recall: Aug 21, 201912. FDA classified it Class II: Sep 27, 201923. Published in FDA’s Enforcement Report: Oct 9, 201934. FDA terminated the recall: Jul 20, 2020420192020
  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.

Similar recalls

Latest medical device recalls

Keep exploring

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-2762-2019 (August 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2762-2019 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