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NexGen recallZ-2115-2017 · Zimmer Biomet, Inc. · initiated Apr 28, 2017

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

Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.

FDA root cause category: Under Investigation by firm

What the company is doing

Zimmer Biomet is conducting a voluntary recall for two lots of the NexGen Offset Stem Extension implants following product complaints indicating that the size etched on the part and labeled on the product packaging were incorrect. Zimmer Biomet distributed recall notices on April 28, 2017, via FedEx. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected]. For further questions, please call (574) 371-3071.

Recall details

Recall number
Z-2115-2017
Status
Terminated
Initiated by the company
Apr 28, 2017
Recalling firm
Zimmer Biomet, Inc.
Quantity
24
Product code
JWH
FDA submissions
K933785
Distribution
Worldwide Distribution - US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria. VA/DOD: None

Product description

NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.

Code information (models, lots, serial numbers)

Item Number: 00-5988-020-14, Lot Number: 63463357, Description: NexGen Offset Stem Ext Size 14, UDI: (01)00889024221475(17)260930(10)63463357; Item Number: 00-5988-020-17, Lot Number: 63463367, Description: (01)00889024221505(17)260930(10)63463367, Manufactured Date: 9/19/2016, Expiration Date: 9/30/2026

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

87 devices cleared under K933785 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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