Recall Z-2870-2026
Biomet, Inc. · initiated July 1, 2026
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: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Codes / lots: UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770
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-2870-2026
- Initiated
- July 1, 2026
- Posted by FDA
- August 3, 2026
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 22
- 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
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2867-2026 Class II | Intramedullary 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-2868-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 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 II | Intramedullary 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-2871-2026 Class II | Intramedullary 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 |