Biomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files
Biomet is recalling 8.0 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves documentation and process deficiencies (incomplete design history files) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet is recalling its 8.0 Cannulated Screw Tap-Bone fixation screw, Item Number 110008467. The product is intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
The recall was initiated because the devices were distributed to the field without having completed design history files or design transfer activities. The affected lots are 624830 and 867210, with a quantity of 10 OUS.
The products were distributed worldwide, including in the United States (specifically NY, GA, FL, MO) and in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers and facilities should stop using the affected devices and contact Biomet for instructions on return or replacement.
The recalled product
- Product
- Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Affected units
- 10
Distribution
Part of a larger recall action
This product is one of 22 recalled by Biomet 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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