Z-0570-2024Class II

Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02

Name: Z-0570-2024 Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Creator: Biomet, Inc.
Published: 2023-11-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2023-11-02 / Open, Classified / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 on 2023-11-02. FDA classified it as Class II and gives the reason as "One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0570-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-02
Posted: 2023-12-18
Recalling firm: Zimmer GmbH
Product: Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 11/2/23 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 for hospitals 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. 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. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s 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 Frida
Quantity in commerce: 10 units
Distribution: US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
Product codes and lots: UDI-DI: 00889024430563; Lot Number: 3145300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0570-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0569-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18
Z-0570-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18

Product code LZO

K200112Class IIZimmer Hip Joint ReplacementZimmer GmbH / cleared 2020-04-10

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)