Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates
Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.
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 is classified as FDA Class II. The hazard involves a medical device failing performance criteria (high revision rate), which poses a risk of harm requiring re-operation, but the source does not report specific injuries or fatalities.
Plain-English summary
Zimmer Biomet, Inc. is recalling AIM Tibial Nails, which are sterile intramedullary fixation rods used to immobilize fractured tibia bones. The recall covers various item numbers and sizes of the AIM Tibial Nail system.
The recall was initiated because the AIM Tibial Nails failed a clinical analysis. Specifically, the surgical revision rate for the implant system exceeded the acceptance criteria defined in the Device Performance Review protocol.
The affected products were distributed worldwide, in the state of Indiana, and in the Republic of Korea. All lots are included in this recall. The source text does not specify the number of units affected or report any specific patient injuries or illnesses.
The recalled product
- Product
- AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE
- Manufacturer
- Zimmer Biomet, Inc.
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 in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. 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.
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