Z-1649-2025Class II

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip...

Name: Z-1649-2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip...
Creator: Zimmer, Inc.
Published: 2025-03-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2025-03-24 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or... on 2025-03-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1649-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-24
Posted: 2025-04-21
Recalling firm: Zimmer GmbH
Product: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 160 units
Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
Product codes and lots: GTIN 00887868376368, All lots distributed with IFU 87-6204-051-99 Rev D or prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1649-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1645-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21
Z-1646-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21
Z-1647-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21
Z-1648-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21
Z-1649-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21

Product code LZO

K181171Class IIZimmer Biomet Ceramic HeadsZimmer, Inc. / cleared 2019-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)