Biomet Recalls Titanium IFS Devices Due to Potential Sterile Seal Breach
Biomet, Inc. is recalling 7,428 units of Titanium IFS devices (Item 909680) because a breach in the sterile seal could lead to loss of sterility.
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: The recall involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Biomet, Inc. is recalling 7,428 units of Titanium IFS devices, Item number 909680, used for bone-to-bone fixation. The recall is due to a potential breach in the sterile seal of the packaging.
A breach in the packaging seal could lead to a loss of sterility for the medical device. The affected lot is identified as Lot 750930.
The devices were distributed worldwide, including in the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan. Healthcare providers should check their inventory for this specific lot number and contact Biomet, Inc. for further instructions.
The recalled product
- Product
- Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 7,428
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 (1)
- Lot 750930
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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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