Biomet Outer Sheath Recalled Due to Failed Sterilization Validation Testing
Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 because the device and tray failed steam sterilization 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 the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 Orthopedic Manual Surgical Instrument (Product Code: 14235). The recall was initiated because the device and the tray that houses it did not pass steam sterilization process validation testing.
The affected units 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 devices and contact Biomet for instructions on how to return or dispose of the product.
The recalled product
- Product
- Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
- Manufacturer
- Biomet
- Affected units
- 136
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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