Zimmer Biomet, Inc. Recall: AIM Tibial Nails intramedullary fixation rod - NON-STERILE; It
Zimmer Biomet, Inc. Recall: AIM Tibial Nails intramedullary fixation rod - NON-STERILE; It is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Zimmer Biomet, Inc.; Product: AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270
| Recalling firm | Zimmer Biomet, Inc. |
|---|---|
| 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 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB DYN 09 X 25.5 810509270 NAIL TIB DYN 09 X 27.0 810509285 NAIL TIB DYN 09 X 28.5 810509300 NAIL TIB DYN 09 X 30. |
| Reason for recall | The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide and US of Indiana and country of the Republic of Korea. |
| Recall initiated | 20180206 |
| Recall number | Z-1197-2018 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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