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Intramedullary Bone Saw recallZ-2867-2026 · Biomet, Inc. · initiated Jul 1, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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 [email protected]. 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 [email protected]. 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

Recall details

Recall number
Z-2867-2026
Status
Open, Classified
Initiated by the company
Jul 1, 2026
Posted by the FDA
Aug 3, 2026
Recalling firm
Biomet, Inc.
Quantity
10
Product code
LXH
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.

Product description

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm

Code information (models, lots, serial numbers)

UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 99346).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page