Z-2762-2019Class II

Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant -

Name: Z-2762-2019 Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant -
Creator: Zimmer GmbH
Published: 2019-08-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-08-21 / Terminated / root cause: labeling and UDI

FDA source

Zimmer GmbH began a recall of Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for... on 2019-08-21. FDA classified it as Class II and gives the reason as "Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2762-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Posted: 2019-09-27
Terminated: 2020-07-20
Recalling firm: Zimmer GmbH
Product: Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
Product code: PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Reason for recall: Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm sent letter 8/21/2019 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, quarantine the product and notify the sales representative 3. Complete Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]
Quantity in commerce: 19 unit worldwide
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.
Product codes and lots: Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2762-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2762-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27

Product code PKC

K171858Class IISidus Stem-Free ShoulderZimmer GmbH / cleared 2017-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)