ALTERA recallZ-2854-2020 · Globus Medical, Inc. · initiated Jul 22, 2020

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Globus Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number: Z-2854-2020
Status: Terminated
Initiated by the company: Jul 22, 2020
Posted by the FDA: Aug 22, 2020
Recalling firm: Globus Medical, Inc.
Product code: MAX
FDA submissions: K140411
Distribution: Worldwide Distribution

Product description

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8

Code information (models, lots, serial numbers)

Part #: 1124.1015; Lot # / UDI #: BAX156KE / (01)00889095069518(10)BAX156KE; BAX156LE / (01)00889095069518(10)BAX156LE; BAX308CE / (01)00889095069518(10)BAX308CE; BAX308DE / (01)00889095069518(10)BAX308DE

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

ALTERA 1124.1015
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports

Product lines

ALTERAGlobus Medical, Inc. · 23 models · 13 reports · 21 recalls

Other devices under the same FDA submission

22 devices cleared under K140411 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

ALTERA 1124.1111
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall4 reports
ALTERA 1124.1011
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall2 reports
ALTERA 1124.1112
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall1 report
ALTERA 1124.1013
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1032
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1033
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1035
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1113
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1115
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1132
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1133
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1135
Globus Medical, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 86164).

Z-2850-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)
Z-2851-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8
Z-2852-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8
Z-2853-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8
Z-2855-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15
Z-2856-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15
Z-2857-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15
Z-2858-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8
Z-2859-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8
Z-2860-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8
Z-2861-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
Z-2862-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15
Z-2863-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15
Z-2864-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15
Z-2865-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8
Z-2866-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
Z-2867-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8
Z-2868-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
Z-2869-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15
Z-2870-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15
Z-2871-2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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