Biomet Intramedullary Bone Saw Blade Recall: Sterile Packaging Risk
Biomet recalls Intramedullary Bone Saw Blade Assembly Model 475625 due to potential sterile packaging damage from exposed blades. Affected units may pose infection risks during surgery.
Lower-risk 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.
What happened, in plain English
Biomet is recalling a specific bone saw blade assembly because it might damage the sterile packaging, increasing infection risk during surgery. Patients using this product should contact Biomet for details. Read more at govinfonow.com/recall/314281-biomet-intramedullary-bone-saw-blade-recall-sterile-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/314281-biomet-intramedullary-bone-saw-blade-recall-sterile-packaging-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2868-2026
Cite this page
“Biomet Intramedullary Bone Saw Blade Recall: Sterile Packaging Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314281-biomet-intramedullary-bone-saw-blade-recall-sterile-packaging-risk. Based on FDA recall #Z-2868-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2868-2026%22&limit=1).
Why it’s dangerous
The saw blade assembly could damage the sterile packaging if the blade is exposed, potentially leading to infection during surgery. This happens because the packaging is not sealed properly when the blade is handled.
Who’s affected
Surgical patients and medical staff using the recalled bone saw blade assembly for orthopedic procedures. Those with the specific model number 475625 are most at risk.
How to tell if you have this one
Check for the model number 475625 on the packaging or product label. The product is used in orthopedic surgeries and sold through medical suppliers.
- Brand
Biomet- Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2867-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm; UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791 | 10 |
| Z-2868-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm; UDI-DI (01)00887868507809(17)360228(10)67818772; Lot 67818772 | 12 |
| Z-2869-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm; UDI-DI (01)00887868507816(17)360221(10)67818764; Lot 67818764 Model No 475630; UDI-DI (01)00887868507816(17)360401(10)67818768; Lot 67818768 Model No 475630; UDI-DI (01)00887868507816(17)360428(10)67954534; Lot 67954534 | 26 |
| Z-2870-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm; UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770 | 22 |
| Z-2871-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm; UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792 | 11 |
What to do — step by step
Check Product Details
Look for the model number 475625 on the packaging or product label to confirm if it's affected.
How this recall unfolded
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2868-2026 (July 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2868-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.