Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach
Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging 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, which aligns with the High severity criteria.
Plain-English summary
Biomet, Inc. is recalling specific lots of the 4.0/5.0mm Cannulated Screw System and BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm). The affected item numbers are 110009810, 110009821, 110009825, and 110009852. These devices are used for the fracture fixation of small bones, small bone fragments, and long bones.
The recall is being conducted 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 180720, 334220, 285750, and 285760. The products 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 and facilities should check their inventory for these specific item numbers and lot numbers.
The recalled product
- Product
- 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
- Manufacturer
- Biomet, Inc.
- Hazard
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 180720 334220 285750 285760
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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