Recall Z-2868-2026

Biomet, Inc. · initiated July 1, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

Codes / lots: UDI-DI (01)00887868507809(17)360228(10)67818772; Lot 67818772

Reason for recall

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

FDA-determined cause: Under Investigation by firm

Action taken

An URGENT MEDICAL DEVICE RECALL notification letter dated 6/22/26 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 this recall notice 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 1-800-348-2759 between 8:00 a.m. and 5:00 p.m. Eastern, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail. 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 1-800-348-2759 between 8:00 a.m. and 5:00 p.m. Eastern, Monday through Friday. Calls received outside of call center operating hours will receive a vo

Details

Recall number
Z-2868-2026
Initiated
July 1, 2026
Posted by FDA
August 3, 2026
Product code
LXH – Orthopedic Manual Surgical Instrument
Quantity
12
Distribution
Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.
Recalling firm
Biomet, Inc., Warsaw, IN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2867-2026 Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… 07/01/2026Open, Classified
Z-2869-2026 Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… 07/01/2026Open, Classified
Z-2870-2026 Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… 07/01/2026Open, Classified
Z-2871-2026 Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… 07/01/2026Open, Classified