CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Intramedullary Bone Saw Blade Assembly recalled by Biomet
Biomet is recalling Intramedullary Bone Saw Blade Assembly. The recall was initiated on 1 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2871-2026
- FDA event ID
- 99346
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jul 2026
- FDA classified
- 3 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2026 | Recall initiated by company | |
| 3 Aug 2026 | Classified by FDA | +33 days |
| 12 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
Where it was distributed
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.
Questions about this recall
Is Intramedullary Bone Saw Blade Assembly recalled?
Yes. Biomet recalled Intramedullary Bone Saw Blade Assembly on 1 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2871-2026.
Why was it 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.
Which lots are affected?
UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biomet
All 279| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | ZipTight, Acute AC Joint Implant, Single Ziploop recalled by Biomet | Biomet | Other | IN |
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