Recall Z-2871-2026 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
| Date | Aug 3, 2026 (initiated Jul 1, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 11 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.