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Alphatec Spine Recalls
46 recalls on record · September 5, 2012 to July 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 16, 2021Medical DevicesFDA
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (0
Hazard: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
June 16, 2021Medical DevicesFDA
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (0
Hazard: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
June 16, 2021Medical DevicesFDA
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (0
Hazard: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
June 16, 2021Medical DevicesFDA
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (0
Hazard: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
June 16, 2021Medical DevicesFDA
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (0
Hazard: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
June 16, 2021Medical DevicesFDA
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (0
Hazard: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
June 14, 2017Medical DevicesFDA
Alphatec Spine, Inc. recalls Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is int
Hazard: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
November 23, 2016Medical DevicesFDA
Alphatec Spine, Inc. recalls Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is
Hazard: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
May 6, 2015Medical DevicesFDA
Alphatec Spine, Inc. recalls 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe
Hazard: During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling.
July 30, 2014Medical DevicesFDA
Alphatec Spine, Inc. recalls Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System,
Hazard: Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
September 4, 2013Medical DevicesFDA
Alphatec Spine, Inc. recalls Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate th
Hazard: The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
June 5, 2013Medical DevicesFDA
Alphatec Spine, Inc. recalls Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilizati
Hazard: Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
March 27, 2013Medical DevicesFDA
Alphatec Spine, Inc. recalls ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLIC
Hazard: The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
November 14, 2012Medical DevicesFDA
Alphatec Spine, Inc. recalls TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodi
Hazard: The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
November 7, 2012Medical DevicesFDA
Alphatec Spine, Inc. recalls ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation
Hazard: The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
September 5, 2012Medical DevicesFDA
Alphatec Spine, Inc. recalls TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical
Hazard: On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate.