Biomet Recalls Screw Instrument Tray Due to Sterilization Validation Failure
Biomet is recalling 705 units of Screw Instrument Trays because the device and tray failed steam sterilization process validation testing.
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 medical device that failed sterilization validation, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet is recalling 705 units of the Biomet Screw Instrument Tray 6.5/80MM (Product Code: 246111003). The recall was initiated because the device and the tray that houses it did not pass steam sterilization process validation testing.
The affected products were distributed nationwide and in foreign markets including China, Australia, Chile, Costa Rica, the Netherlands, and Switzerland. All lots of the product are included in this recall.
Healthcare facilities and consumers should stop using the affected trays and contact Biomet for further instructions on how to return or replace the products.
The recalled product
- Product
- Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
- Manufacturer
- Biomet
- Affected units
- 705
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
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