Z-2866-2020Class II

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8

Name: Z-2866-2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
Creator: Globus Medical, Inc.
Published: 2020-07-22
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2020-07-22 / Terminated / root cause: manufacturing process

FDA source

Globus Medical, Inc. began a recall of ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8 on 2020-07-22. FDA classified it as Class II and gives the reason as "Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2866-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-22
Posted: 2020-08-22
Terminated: 2021-08-19
Recalling firm: Globus Medical, Inc.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: manufacturing process
FDA 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.
Distribution: Worldwide Distribution
Product codes and lots: Part #: 1124.1212; Lot # / UDI #: BAX103XE / (01)00889095069884(10)BAX103XE; BAX109NE / (01)00889095069884(10)BAX109NE; BAX250HE / (01)00889095069884(10)BAX250HE; BAX250FE / (01)00889095069884(10)BAX250FE; BAX256CE / (01)00889095069884(10)BAX256CE; BAX257UE / (01)00889095069884(10)BAX257UE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2866-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2850-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2851-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2852-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2853-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2854-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2855-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2856-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2857-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2858-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2859-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2860-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2861-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2862-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2863-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2864-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2865-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2866-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2867-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2868-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2869-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2870-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22
Z-2871-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22

Product code MAX

K140411Class IIAltera SpacerGlobus Medical, Inc. / cleared 2014-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)