Food, drugs, devices › Zimmer GmbH
Device recall: Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem
FDA enforcement event 83689 is a device recall by Zimmer GmbH of Winterthur, N/A, initiated 21 Aug 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 20 Jul 2020. Initiation: voluntary: firm initiated. Zimmer GmbH has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zimmer GmbH, Winterthur, N/A, Switzerland.
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."
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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2762-2019 | 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… | 19 unit worldwide | Class II | Terminated | 9 Oct 2019 |
Context
Other enforcement events for Zimmer GmbH
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.