FDA Medical Device Recalls (openFDA)
Globus Medical, Inc.: ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
- Recall number
- Z-2861-2020
- Recalling firm
- Globus Medical, Inc.
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
- Status
- Terminated
- Initiated
- 2020-07-22
- Posted
- 2020-08-22
- Terminated
- 2021-08-19
- Reason
- Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- Root cause
- Nonconforming Material/Component
- Action
- A customer letter dated July 22, 2020 was mailed to customers. In this letter customers are instructed to immediately examine their inventory and determine if they have any of the affected implants. Alternatively, they may return all ALTERA inventory and Globus will sort out the affected implants and replace inventory with conforming implants. Report any adverse effects believed to be associated with the product to Globus Medical immediately by filling out the attached Response Card.
- Quantity
- not on file
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Part #: 1124.1115; Lot # / UDI #: BAX159RE / (01)00889095069716(10)BAX159RE; BAX178JE / (01)00889095069716(10)BAX178JE; BAX208RE / (01)00889095069716(10)BAX208RE; BAX229UE / (01)00889095069716(10)BAX229UE; BAX250BE / (01)00889095069716(10)BAX250BE; BAX308BE / (01)00889095069716(10)BAX308BE; BAX347YE / (01)00889095069716(10)BAX347YE; BAX351KE / (01)00889095069716(10)BAX351KE
- 510(k) numbers
- ["K140411"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3004142400
- Firm city
- Audubon
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28