| Date Initiated by Firm | July 01, 2026 |
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| Date Posted | August 03, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2867-2026 |
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| Recall Event ID |
99346 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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| Product | Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475620
Product Description: Intramedullary Bone Saw Blade Assembly 12mm |
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| Code Information |
UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791
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| FEI Number |
1825034
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Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
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| For Additional Information Contact | 411 Technical Services
800-348-2759 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 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 |
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| Quantity in Commerce | 10 |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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