Biomet Recalls Sterile Trac System Thinflap Burr Hole Plates
Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates 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, which corresponds to a High severity score of 3 per the rubric.
Plain-English summary
Biomet, Inc. is recalling specific lots of the Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12. This medical device is used for the fixation of cranial bone. The recall involves 7,428 units from Lot 078390.
The recall was initiated because specific lots of multiple 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 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. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial 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)
- Lot 078390
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.
See all 16 products in this recall →Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · loss of sterility
See all →- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26
- HighProxima Drape surgical drapes recalled due to potential sterility loss
FDA (Devices) · 2025-03-26