Food, drugs, devices › Zimmer, Inc.
Device recall: NexGen Precoat Stemmed Tibial Plate Size 5
FDA enforcement event 92531 is a device recall by Zimmer, Inc. of Warsaw, IN, initiated 19 May 2023 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 917 device enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 29 May 2026. Initiation: voluntary: firm initiated. Zimmer, Inc. has 108 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, Inc., Warsaw, IN.
Reason for recall
"Device outer packaging was incorrectly labeled."
Distribution
"International distribution in the country of India."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2092-2023 | NexGen Precoat Stemmed Tibial Plate Size 5 | N/A | Class II | Terminated | 12 Jul 2023 |
Context
Other enforcement events for Zimmer, Inc.
All 108 events for Zimmer, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Device outer packaging was incorrectly labeled."
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: "International distribution in the country of India."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 May 2026. "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.