Z-2870-2026Class II

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone...

Name: Z-2870-2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone...
Creator: Biomet, Inc.
Published: 2026-07-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2026-07-01 / Open, Classified / root cause: packaging

FDA source

Biomet, Inc. began a recall of Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm on 2026-07-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2870-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-01
Posted: 2026-08-03
Recalling firm: Zimmer GmbH
Product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: packaging
FDA 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 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
Quantity in commerce: 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.
Product codes and lots: UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2870-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2867-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2868-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2869-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2870-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2871-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)