Biomet Compress Device Short Anchor Plug Recalled Due to Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (23 MM) due to potential metal burrs in transverse holes that may prevent proper insertion of surgical instruments, potentially extending surgery time. Distribution includes US and multiple international countries.
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 medical device with a manufacturing defect affecting proper surgical instrument insertion, potentially extending surgery time. Although no reported injuries or illnesses are cited, this is a risk-of-harm product affecting an invasive surgical procedure.
Plain-English summary
Biomet, Inc. is recalling the Compress Device Short Anchor Plug, 23 MM (Item Number 178565), an orthopedic surgical device used for correction of unsuccessful osteotomies, arthrodesis, or previous joint replacements.
The anchor plugs potentially have metal burrs in the transverse holes of the device. These burrs may prevent the drill or pins from passing through during surgical installation, potentially extending the length of the surgical procedure.
The device was distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. The affected lot number is 930790.
Healthcare providers with affected devices should contact Biomet for further information and instructions regarding the recalled devices.
The recalled product
- Product
- Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
- Manufacturer
- Biomet, Inc.
- Hazard
- metal-burrs
- surgical-obstruction
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)
- Lot Numbers/UDI: 930790 (01)00880304528697(17)270709(10)930790
Distribution
Distributed nationwide across the United States.
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