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Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper… recallZ-1646-2025 · Zimmer, Inc. · initiated Mar 24, 2025

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 associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

FDA root cause category: Under Investigation by firm

What the company is doing

Zimmer Biomet issued an URGENT MEDICAL DEVICE RECALL CORRECTION - PHASE 1 notice to its consignees on 03/24/2025 via email and courier. The notice explains the issue, potential risk, and requested the following: Distributors: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 3. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 4. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. Risk Manager Responsibilities: 1. Review this correction notice and ensure that affected personnel, including surgeons, 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 this notice 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 acknowledgeme

Recall details

Recall number
Z-1646-2025
Status
Open, Classified
Initiated by the company
Mar 24, 2025
Posted by the FDA
Apr 21, 2025
Recalling firm
Zimmer, Inc.
Quantity
215 units
Product code
LZO
FDA submissions
K181171
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.

Product description

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

Code information (models, lots, serial numbers)

GTIN 00887868376337, All lots distributed with IFU 87-6204-051-99 Rev D or prior

Devices named in this recall

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

Other devices under the same FDA submission

7 devices cleared under K181171 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96493).

Sources and updates

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