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M/L Taper Hip Prosthesis Extended Offset, Reduced Neck… recallZ-2519-2023 · Zimmer, Inc. · initiated Jul 26, 2023

Open, Classified

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

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

FDA root cause category: Mixed-up of materials/components

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 7/26/23 was 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. You are receiving this notice because you have implanted one of the impacted stems based on our records. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. It is anticipated that the fit of the stem would have been highly detectable, for example a physical size 4 stem sitting lower than expected in a bone prepared for size 6, or vice versa and the stem sitting proud. During surgery, the available offsets in femoral head implants may have provided the necessary flexibility to appropriate

Recall details

Recall number
Z-2519-2023
Status
Open, Classified
Initiated by the company
Jul 26, 2023
Posted by the FDA
Sep 7, 2023
Recalling firm
Zimmer, Inc.
Quantity
24 units
Product code
JDI
FDA submissions
K200823
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.

Product description

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

Code information (models, lots, serial numbers)

Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215

Devices named in this recall

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

Other devices under the same FDA submission

27 devices cleared under K200823 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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