Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates
Zimmer Biomet is recalling AIM Tibial Nails because they failed a clinical analysis showing surgical revision rates exceeded acceptance criteria.
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 rates), which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling AIM Tibial Nails, which are non-sterile intramedullary fixation rods used to immobilize fractured tibia bones. The recall covers various item numbers and sizes, including 8mm, 9mm, 10mm, 11mm, 12mm, and 13mm diameters, with lengths ranging from 25.5 cm to 42.0 cm.
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 established in the Device Performance Review protocol. The source text does not specify the number of affected units, the exact dates of distribution, or the number of patients affected.
The affected devices were distributed worldwide, in the state of Indiana, and in the Republic of Korea. Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for further instructions on return or replacement.
The recalled product
- Product
- AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 81
- 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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