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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen

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 Class 2 Device Recall NexGensee related information
Date Initiated by FirmMay 19, 2023
Date PostedJuly 05, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2092-2023
Recall Event ID 92531
510(K)NumberK173057 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductNexGen Precoat Stemmed Tibial Plate Size 5
Code Information Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactCustomer Service
574-371-3071
Manufacturer Reason
for Recall		Device outer packaging was incorrectly labeled.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm distributed recall notifications by email on 5/19/2023. Customers are asked to review the recall notification and distribute to team members so they are aware of its contents. Additionally, customers are to identify and quarantine any affected devices, complete the provided Inventory Return Certification form, and ship affected product back to Zimmer. Customers are to retain a copy of the Inventory Return Certification for their records. Customers with any questions may call 574-371-3071 or email CorporateQuality.PostMarket@zimmerbiomet.com.
DistributionInternational distribution in the country of India.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
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