Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which involves a remote possibility of adverse health consequences.
Plain-English summary
Biomet, Inc. is conducting a medical device recall for various sizes of the Intramedullary Bone Saw Blade Assembly (Model/Catalog Number: 475640).
The recall was initiated because an exposed saw blade may have caused damage to the sterile barrier packaging, potentially compromising the sterility of the device.
Affected products include the Intramedullary Bone Saw Blade Assembly 16mm (Lot 67818792). Distribution details are contained in the manufacturer's initial consignee and distribution history lists.
The recalled product
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 11
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 (2)
- UDI-DI (01)00887868507830(17)360316(10)67818792
- Lot 67818792
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.
See all 5 products in this recall →Related recalls
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