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 seal could lead to loss of sterility.
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 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 the 6.5/8.0mm Cannulated Screw System and BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm). The recall involves 7,428 units distributed worldwide, including the United States, Canada, and various international markets.
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.
Healthcare providers and facilities should check their inventory for the affected item numbers and lot numbers listed in the recall notice. If the devices are found, they should be removed from use and returned to Biomet, Inc. in accordance with the recall instructions.
The recalled product
- Product
- 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 7,428
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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