Intramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
Biomet, Inc. is recalling various sizes of 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 3/5 (High).
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: The product is a medical device with a potential risk of harm due to compromised sterility, which falls under high-risk products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is conducting a medical device recall for various sizes of the Intramedullary Bone Saw Blade Assembly (Model/Catalog Number: 475630). The recall was initiated because an exposed saw blade may have caused damage to the sterile barrier packaging.
This recall affects specific lots of the 14mm Intramedullary Bone Saw Blade Assembly. Affected units include Lot 67818764, Lot 67818768, and Lot 67954534.
Distribution information is contained in the manufacturer's initial consignee and distribution history lists. Users should refer to these lists to identify if they have received the affected products.
The recalled product
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
- Manufacturer
- Biomet, Inc.
- Affected units
- 26
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 (6)
- 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
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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