Biomet TUNNELOC Round Head Interference Screw Recalled for Undersized Tip Hole
Biomet is recalling 44 TUNNELOC Round Head Interference Screws because the hole at the tip is undersized. The defect may affect the device's performance during orthopedic procedures.
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 2/5 (Moderate).
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 source text describes a manufacturing defect (undersized hole) without reporting any injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Biomet, Inc. is recalling 44 units of the TUNNELOC Round Head Interference Screw, 8mm x 25mm. The recall is due to a manufacturing defect where the through-hole at the tip of the screw is undersized. These devices are intended for use in arthroscopic and orthopedic reconstructive procedures, specifically for the fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The affected units were distributed worldwide, including in the United States (California, Florida, Illinois, Alabama, Ohio, Kentucky, and Texas) and internationally to Australia, Colombia, Mexico, the Netherlands, and Chile. The specific catalog number is 909668 and the lot number is 716710.
Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices. No specific instructions for immediate patient action are provided in the source text beyond the recall notification.
The recalled product
- Product
- TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 44
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)
- Catalog Number: 909668 Lot Number Identification: 716710
Distribution
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