Home / Recalls / Globus Medical, Inc. / Z-2857-2020

Z-2857-2020 Class II Terminated

Recalled by Globus Medical, Inc. — Audubon, PA

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
July 22, 2020
Termination Date
August 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿

Reason for Recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Distribution Pattern

Worldwide Distribution

Code Information

Part #: 1124.1035; Lot # / UDI #: BAX112UE / (01)00889095069570(10)BAX112UE; BAX212UE / (01)00889095069570(10)BAX212UE; BAX219JE / (01)00889095069570(10)BAX219JE; BAX348AE / (01)00889095069570(10)BAX348AE; BAX367GE / (01)00889095069570(10)BAX367GE; BAX431UE / (01)00889095069570(10)BAX431UE

Other recalls by Globus Medical, Inc.

  • Z-1657-2025 Class II — MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; (April 3, 2025)
  • Z-1007-2024 Class II — ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No (December 15, 2023)
  • Z-0996-2024 Class II — Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, prepar (December 11, 2023)
  • Z-0995-2024 Class II — Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prepara (December 11, 2023)
  • Z-0997-2024 Class II — Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and (December 11, 2023)
  • Z-0642-2024 Class I — ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 (December 7, 2023)
  • Z-2854-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ (July 22, 2020)
  • Z-2852-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ (July 22, 2020)
  • Z-2862-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ (July 22, 2020)
  • Z-2855-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ (July 22, 2020)