Recall Z-1811-2021— Alphatec Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2021-04-26, terminated 2022-11-17. It names one FDA 510(k) clearance: K200995. Product: Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408. Reason: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively..
- Recalling firm
- Alphatec Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-26
- Terminated
- 2022-11-17
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Reason for recall
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Data sourced from openFDA. This site is unofficial and independent of the FDA.