Z-0471-2023Class II

NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

Name: Z-0471-2023 NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
Creator: Zimmer, Inc.
Published: 2022-12-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-12-06 / Open, Classified

FDA source

Zimmer, Inc. began a recall of NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 on 2022-12-06. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0471-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-06
Posted: 2022-12-09
Recalling firm: Zimmer GmbH
Product: NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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 the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 12/6/22 were sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. 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]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. It is recommended that for patients implanted with the NexGen Stemmed Option Tibial Component with either the LPS Flex or LPS Flex GSF Femoral Components, maintain an appropriate index of suspicion for patients with any new pain, inability to bear weight, swelling or instability of the knee. The UK NJR data suggests that tibial component loosening is a key cause of the increased TKR revisions. If your patient experiences any new pain or other symptoms related to the TKR, it is recommended that additional clinical and/or radiographic follow-up is completed. 3. If an impacted
Quantity in commerce: 284
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: All Unexpired Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0471-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0466-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0467-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0468-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0469-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0470-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0471-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09

Product code JWH

K872379Class IIInsall/burstein* II Modular Total KneeZimmer, Inc. / cleared 1987-10-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)