Marquette, MI, United States
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls
4 recalls recorded since 2018, most recently on 15 January 2021. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 January 2021
- Reason
- Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1222-2021, Z-1227-2021, Z-1217-2021, Z-1221-2021, Z-1243-2021, Z-1235-2021, Z-1232-2021, Z-1224-2021, Z-1223-2021, Z-1241-2021, Z-1238-2021, Z-1229-2021 and 29 more
- CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) def
- CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defi
- CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defi
- CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) def
- CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) def
- CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defi
- CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defi
- CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defi
- and 33 more product lines
Terminated Class II Medical devices
- Recall started
- 24 September 2020
- Terminated
- 16 September 2024
- Reason
- The Streamline Navigation System taps have experienced binding with other devices.
- Distribution
- US Nationwide distribution including in the state of Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0300-2021, Z-0299-2021
- Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-I
- Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-M
Ongoing Class II Medical devices
- Recall started
- 24 September 2020
- Reason
- System does not include a drill guide.
- Distribution
- Distributed to one distributor in Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0322-2021
- 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.
Terminated Class II Medical devices
- Recall started
- 11 September 2020
- Terminated
- 23 May 2024
- Reason
- The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
- Distribution
- Product distributed to Surgalign, a distributor located in Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0320-2021
- Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDE
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.