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NexGen Option Stemmed Tibial Component Size 5, Item Number… recallZ-0468-2023 · Zimmer, Inc. · initiated Dec 6, 2022

Class II Open, Classified All recalls posted in December 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0468-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 6, 2022
Posted by the FDA
Dec 9, 2022
Recalling firm
Zimmer, Inc.
Quantity
2460
Product code
JWH
FDA submissions
K872379
Distribution
Worldwide - US Nationwide distribution.

Product description

NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

Code information (models, lots, serial numbers)

All Unexpired Lots

Other devices under the same FDA submission

21 devices cleared under K872379 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91073).

Sources and updates

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