OSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
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: FDA Class II device with missing critical structural components. While no illnesses or injuries have been reported, the missing bolts directly prevent proper device assembly and will require extended surgery to resolve. This represents a significant risk of surgical complication without confirmed patient harm.
Plain-English summary
Biomet, Inc. is recalling OSS Modular Arthrodesis Nails (Item Number CP260602) due to a manufacturing defect. Some units have been shipped missing the four small locking collar bolts, which are critical components for proper assembly and function of the device.
The missing bolts will be discovered during surgical use, requiring surgeons to locate a replacement and extend the operating time. Healthcare facilities that received affected units (Lot 136620) should immediately quarantine them and not use them for patient procedures. Contact Biomet if you have received affected units.
The recalled product
- Product
- OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
- Manufacturer
- Biomet, Inc.
- Hazard
- missing-components
- incomplete-assembly
- surgical-complication-risk
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)
- UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620
Distribution
Distributed nationwide across the United States.
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