Home / Recalls / RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / Z-0322-2021

Z-0322-2021 Class II Ongoing

Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) — Marquette, MI

Recall Details

Product Type
Devices
Report Date
November 11, 2020
Initiation Date
September 24, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
76 units

Product Description

Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.

Reason for Recall

System does not include a drill guide.

Distribution Pattern

Distributed to one distributor in Michigan.

Code Information

Lots 370855 373847 373848 373849 377629 373850 373846

Other recalls by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

  • Z-1236-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Numb (January 15, 2021)
  • Z-1207-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Numbe (January 15, 2021)
  • Z-1229-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number (January 15, 2021)
  • Z-1231-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number (January 15, 2021)
  • Z-1241-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Numbe (January 15, 2021)
  • Z-1206-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Numbe (January 15, 2021)
  • Z-1219-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number (January 15, 2021)
  • Z-1209-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Numbe (January 15, 2021)
  • Z-1238-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Numbe (January 15, 2021)
  • Z-1232-2021 Class II — CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number (January 15, 2021)