Biomet Recalls Cannulated Screw Systems Due to Potential Sterile Seal Breach
Biomet is recalling specific lots of cannulated screw systems 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 3.0mm Cannulated Screw Systems and BCS Cannulated Screw Systems. The affected products are used for fracture fixation of small bones, small bone fragments, and long bones. The recall involves 7,428 units distributed worldwide, including the United States, Canada, and various international regions.
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 item numbers are 110009787, 110009790, 110009794, 110009796, 110009798, and 110009800. The specific lot numbers involved are 180140, 180150, 180160, 371180, 371190, and 371250.
Healthcare providers and patients should check their inventory and records for these specific item and lot numbers. If the affected devices are found, they should be removed from use and returned to Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
- Manufacturer
- Biomet, Inc.
- 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 180140 180150 180160 371180 371190 371250
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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