Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing
Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with reports of fracturing and remaining in the device implant, which constitutes a significant injury risk and potential for serious harm, aligning with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling certain lots of the Phoenix Nail System 3.5mm Inserter Connector, Short (Model Number 14-441045). The recall affects 2,470 units manufactured before March 30, 2017. The product is intended for use with an intramedullary nail system for the alignment, stabilization, and fixation of fractures.
The recall was initiated due to reports that the instruments fractured and remained in the device implant. The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in Australia, Brazil, Canada, Chile, Colombia, El Salvador, the Netherlands, Japan, Costa Rica, Spain, and Thailand.
Healthcare providers and patients should check their inventory and medical records for the specific packaging lot numbers and laser markings listed in the official recall notice. If a patient has received an implant from these specific lots, they should contact their healthcare provider to discuss the potential risk of retained fractured instrument fragments.
The recalled product
- Product
- Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00,
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 2,470
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 (12)
- Lots manufactured before March 30
- ZB121002 ZB130902 90225701 90224951
- ZB120801 90229981 ZB120201 ZB141201 ZB131001
- ZB130901 ZB160502 ZB151001 3050001
- 90229981 ZB151001 ZB121002
- ZB121001 ZB151001 ZB120701 ZB150702 3050001 RS08C028 RS08A014
- RS08A032
- RS08C028
- RS08A032 F4C7912 90227192 F4C7912 90227192 F4C7912 90227191
- 90227192
- 90229981
- 90229021 F4C7912 90229981
Distribution
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