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NexGen recallZ-0630-2019 · Zimmer Biomet, Inc. · initiated Oct 31, 2018

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 Biomet, 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

Screw is missing from the package

FDA root cause category: Process control

What the company is doing

Zimmer Biomet issued "URGENT MEDICAL DEVICE RECALL" Letter on 10/31/18 via email and FedEx to the consumer/user level, including any intermediate wholesale or retail consignees, distributors and Risk managers. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals that have previously used the product. Hospital risk managers responsibilities include the following: 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. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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].

Recall details

Recall number
Z-0630-2019
Status
Terminated
Initiated by the company
Oct 31, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
19 units
Product code
JWH
FDA submissions
K152494
Distribution
Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.

Product description

NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.

Code information (models, lots, serial numbers)

Lot Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336

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

3 devices cleared under K152494 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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