Z-2870-2020 Class II Terminated
FDA device recall Z-2870-2020 was initiated by Globus Medical, Inc. on July 22, 2020 and is designated Class II. 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. The recall status is terminated (terminated August 19, 2021). Affected quantity: N/A.
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, 10x36, 10-14mm, 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 #: 1124.1233; Lot # /UDI #: BAX196AE / (01)00889095069952(10)BAX196AE; BAX196CE / (01)00889095069952(10)BAX196CE