Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Reason for recall: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. Distribution: U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI. Quantity: 568 devices Lot/code info: Part Number and Description: LS-397-0705 Implant Trial, 10 x 7 x 28mm x 5¿, Tx UDI-DI code: M711LS39707050 Serial Numbers: 001-012 013-025 Part Number and Description: LS-397-0805 Implant Trial, 10 x 8 x 28mm x 5¿, Tx UDI-DI Code: M711LS39708050 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-0905 Implant Trial, 10 x 9 x 28mm x 5¿, Tx UDI-DI code: M711LS39709050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-397-1005 Implant Trial, 10 x 10 x 28mm x 5¿, Tx UDI-Di code: M711LS39710050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-397-1105 Implant Trial, 10 x 11 x 28mm x 5¿, Tx UDI-DI code: M711LS39711050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-397-0810 Implant Trial, 10 x 08 x 28mm x 10¿, Tx UDI_DI code: M711LS39708100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-0910 Implant Trial, 10 x 09 x 28mm x 10¿, Tx UDI-DI code: M711LS39709100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-1010 Implant Trial, 10 x 10 x 28mm x 10¿, Tx UDI-DI code: M711LS39710100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-1110 Implant Trial, 10 x 11 x 28mm x 10¿, Tx +M711LS39711100E 001-012 013-026 Part Number and Description: LS-397-0912 Implant Trial, 10 x 09 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39709120 Serial Numbers: 001-012 013-024 Part Number and Description: LS-397-1012 Implant Trial, 10 x 10 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39710120 Serial Numbe
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.