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NexGen recallZ-2092-2023 · Zimmer, Inc. · initiated May 19, 2023

Terminated

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

Device outer packaging was incorrectly labeled.

FDA root cause category: Under Investigation by firm

What the company is doing

The 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 [email protected].

Recall details

Recall number
Z-2092-2023
Status
Terminated
Initiated by the company
May 19, 2023
Posted by the FDA
Jul 5, 2023
Recalling firm
Zimmer, Inc.
Product code
JWH
FDA submissions
K173057
Distribution
International distribution in the country of India.

Product description

NexGen Precoat Stemmed Tibial Plate Size 5

Code information (models, lots, serial numbers)

Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

375 devices cleared under K173057 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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