Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00889024430556, Lot Number: 3145299
Products Sold
UDI-DI: 00889024430556; Lot Number: 3145299
Biomet, Inc. is recalling Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 due to 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 pro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, MD, MI, NC, OH, OK, TN, TX
Page updated: Jan 10, 2026