Intramedullary Bone Saw Blade Assembly Recall for Packaging Damage
Zimmer Biomet recalls Intramedullary Bone Saw Blade Assemblies due to potential sterile barrier packaging damage from exposed saw blades. FDA Class II medical device recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with risk-of-harm potential where injury has not yet been reported. Compromised sterile barrier packaging in surgical devices presents infection risk but no actual injuries documented.
Plain-English summary
Zimmer Biomet is conducting a medical device recall removal for the Intramedullary Bone Saw Blade Assembly, Model/Catalog Number 475635, due to potential sterile barrier packaging damage caused by an exposed saw blade. The affected product is a 15mm Intramedullary Bone Saw Blade Assembly manufactured by Biomet, Inc.
The recall is classified as FDA Class II, indicating potential for temporary or medically reversible adverse health consequences. The hazard exists because the saw blade may be exposed, which could damage the sterile barrier packaging and potentially compromise the sterility of the device.
The recall affects specific lots identified as Lot 67818769 and Lot 67818770, with UDI-DI identifiers 00887868507823. Distribution details are available in the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History documents.
Healthcare facilities and surgical centers should immediately stop using the affected devices and quarantine any in inventory. Consumers should return affected products to their point of purchase or contact Zimmer Biomet for instructions. Healthcare providers should report any adverse events involving these devices to FDA MedWatch.
The recalled product
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
- Manufacturer
- Biomet, Inc.
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI (01)00887868507823(17)360224(10)67818769
- Lot 67818769 Model No 475635
- UDI-DI (01)00887868507823(17)360225(10)67818770
- Lot 67818770
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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