Device recall: Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade…

Class II FDA enforcement event 99346. Recall start date: 1 Jul 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Biomet, Inc. started this device recall on 1 Jul 2026. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 99346 has 5 product records. The first FDA enforcement report date is 12 Aug 2026. The record gives the status Ongoing.

FDA enforcement report The 5 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

5 product records in the event.

FDA event 99346: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2867-2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm	10	Class II	Ongoing	12 Aug 2026
Z-2868-2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm	12	Class II	Ongoing	12 Aug 2026
Z-2869-2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm	26	Class II	Ongoing	12 Aug 2026
Z-2870-2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm	22	Class II	Ongoing	12 Aug 2026
Z-2871-2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm	11	Class II	Ongoing	12 Aug 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class II: 87%
Product records in this event: 5Median of the firm: 1
Events of the firm on the register: 84

Other events of the firm

Other FDA enforcement events of Biomet, Inc.
Initiated	Product (first record)	Type	Class	Records
23 Sep 2025	BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Rep	Device	Class II	1
9 Sep 2025	Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080	Device	Class II	1
21 Oct 2024	JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357	Device	Class II	1
17 May 2024	RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206	Device	Class II	1
13 Mar 2024	Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi	Device	Class II	1
2 Nov 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01	Device	Class II	2
9 Oct 2023	Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ	Device	Class II	19
6 Feb 2023	G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462	Device	Class II	1
29 Dec 2022	(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number:	Device	Class II	2
15 Dec 2022	Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjun	Device	Class II	1

Biomet, Inc.: all 84 events

Official channels

FDA enforcement report Z-2867-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 99346. https://recallregister.com/fda/ii/99346/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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.
What quantity of product is in FDA event 99346?: The event has 5 product records. The first record gives this quantity: 10
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 572 device events that started in 2026 are in Class II.