Biomet RapidFire Clip Recall Due to Potential Sterile Seal Breach
Biomet is recalling specific lots of RapidFire Clips used for craniofacial bone fixation 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 specific lots of RapidFire Clips (Item Number 95-0154) used for the fixation of craniofacial bone. The recall involves 7,428 units distributed worldwide, including the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan.
The recall was initiated because specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility of the device.
The affected lots are 080580, 231760, 359160, 359170, 381910, 382870, 382900, 382970, and 383010. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
- 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)
- Lots 080580 231760 359160 359170 381910 382870 382900 382970 383010
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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