Food, drugs, devices › Zimmer, Inc.
Device recall: NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
FDA enforcement event 91073 is a device recall by Zimmer, Inc. of Warsaw, IN, initiated 6 Dec 2022 and classified Class II, with 6 product records.
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 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. 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
"Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in…"
Distribution
"Worldwide - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0466-2023 | NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 | 1673 | Class II | Ongoing | 21 Dec 2022 |
| Z-0467-2023 | NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 | 2092 | Class II | Ongoing | 21 Dec 2022 |
| Z-0468-2023 | NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 | 2460 | Class II | Ongoing | 21 Dec 2022 |
| Z-0469-2023 | NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 | 1366 | Class II | Ongoing | 21 Dec 2022 |
| Z-0470-2023 | NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 | 1049 | Class II | Ongoing | 21 Dec 2022 |
| Z-0471-2023 | NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 | 284 | Class II | Ongoing | 21 Dec 2022 |
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: "Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in…"
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 - US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.