Biomet Recalls Phoenix Retrograde Femoral Connecting Bolts Due to Fit Issues
Biomet is recalling 75 Phoenix Retrograde Femoral Connecting Bolts because an undersized diameter may cause the hex driver to get stuck, delaying surgery.
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: The recall involves a high-risk medical device where a mechanical defect may cause a delay in surgery, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. has initiated a recall of 75 units of the Phoenix Retrograde Femoral Connecting Bolt (Part Number 14-442021, Lot Number 757910). The product is indicated for the alignment, stabilization, and fixation of fractures caused by trauma or disease, as well as the fixation of femurs surgically prepared for deformity correction.
The recall was initiated because the connecting bolt has an undersized diameter specification. This defect may cause an interference fit with the 4mm hex driver (Part Number 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt, the device cannot be taken apart, which may result in a delay in surgery.
The affected units were distributed worldwide, including nationwide in the United States (specifically CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI) and in the Netherlands, Costa Rica, Japan, and San Juan. Healthcare providers and patients should contact Biomet for further instructions regarding the recall.
The recalled product
- Product
- Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surg
- Manufacturer
- Biomet, Inc.
- Affected units
- 75
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: 14-442021 and lot number:757910
Distribution
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