Is ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ recalled?

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

Agency Publication Date: August 22, 2020

Affected Products

Product: ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿

Part #: 1124.1032; Lot # / UDI #: BAX095XE / (01)00889095069549(10)BAX095XE; BAX175CE / (01)00889095069549(10)BAX175CE; BAX185BE / (01)00889095069549(10)BAX185BE; BAX299LE / (01)00889095069549(10)BAX299LE

Product: ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿

Part #: 1124.1012; Lot # / UDI #: BAX096BE / (01)00889095258363(10)BAX096BE; BAX112TE / (01)00889095258363(10)BAX112TE; BAX112SE / (01)00889095258363(10)BAX112SE; BAX177UE / (01)00889095258363(10)BAX177UE; BAX195VE / (01)00889095258363(10)BAX195VE; BAX229TE / (01)00889095258363(10)BAX229TE; BAX279WE / (01)00889095258363(10)BAX279WE; BAX288HE / (01)00889095258363(10)BAX288HE; BAX299GE / (01)00889095258363(10)BAX299GE; BAX367FE / (01)00889095258363(10)BAX367FE

Product: ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿

Part #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE

Product: ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

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

Product: ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)

Part #: 1124.1111S; Lot#/UDI #: GBX132UC / (01)00889095720723(17)250511(10)GBX132UC

Product: ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

Part #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE

Product: ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Part #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE

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

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

Product: ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿

Part #: 1124.1111; Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME; BAX156NE / (01)00889095069679(10)BAX156NE; BAX167PE / (01)00889095069679(10)BAX167PE; BAX229VE / (01)00889095069679(10)BAX229VE; BAX290TE / (01)00889095069679(10)BAX290TE; BAX290UE / (01)00889095069679(10)BAX290UE; BAX294WE / (01)00889095069679(10)BAX294WE; BAX376DE / (01)00889095069679(10)BAX376DE; BAX376CE / (01)00889095069679(10)BAX376CE

Product: ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿

Part #: 1124.1112; Lot # / UDI #: BAX137PE / (01)00889095069686(10)BAX137PE; BAX167SE / (01)00889095069686(10)BAX167SE; BAX178FE / (01)00889095069686(10)BAX178FE; BAX208LE / (01)00889095069686(10)BAX208LE; BAX250CE / (01)00889095069686(10)BAX250CE; BAX348CE / (01)00889095069686(10)BAX348CE; BAX431NE / (01)00889095069686(10)BAX431NE

Product: ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿

Part #: 1124.1113; Lot # / UDI #: BAX178LE / (01)00889095069693(10)BAX178LE; BAX178KE / (01)00889095069693(10)BAX178KE; BAX189PE / (01)00889095069693(10)BAX189PE; BAX348EE / (01)00889095069693(10)BAX348EE

Product: ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿

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

Product: ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿

Part #: 1124.1132; Lot# / UDI #: BAX138HE / (01)00889095069747(10)BAX138HE; BAX177XE / (01)00889095069747(10)BAX177XE; BAX185CE / (01)00889095069747(10)BAX185CE; BAX195EE / (01)00889095069747(10)BAX195EE; BAX208NE / (01)00889095069747(10)BAX208NE; BAX299PE / (01)00889095069747(10)BAX299PE; BAX315CE / (01)00889095069747(10)BAX315CE; BAX348BE / (01)00889095069747(10)BAX348BE

Product: ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿

Part #: 1124.1133; Lot # / UDI #: BAX108TE / (01)00889095069754(10)BAX108TE; BAX178ME / (01)00889095069754(10)BAX178ME; BAX208TE / (01)00889095069754(10)BAX208TE; BAX299NE / (01)00889095069754(10)BAX299NE; BAX413CE / (01)00889095069754(10)BAX413CE; BAX413GE / (01)00889095069754(10)BAX413GE

Product: ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿

Part #: 1124.1135; Lot # / UDI #: BAX178PE / (01)00889095069778(10)BAX178PE; BAX236NE / (01)00889095069778(10)BAX236NE; BAX398UE / (01)00889095069778(10)BAX398UE; BAX431SE / (01)00889095069778(10)BAX431SE

Product: ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿

Part #: 1124.1211; Lot # / UDI #: BAX103VE / (01)00889095069877(10)BAX103VE; BAX109ME / (01)00889095069877(10)BAX109ME; BAX203PE / (01)00889095069877(10)BAX203PE; BAX315BE / (01)00889095069877(10)BAX315BE; BAX359ME / (01)00889095069877(10)BAX359ME; BAX412WE / (01)00889095069877(10)BAX412WE

Product: ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿

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

Product: ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿

Part #: 1124.1213; Lot # / UDI #: BAX128PE / (01)00889095069891(10)BAX128PE; BAX207CE / (01)00889095069891(10)BAX207CE; BAX128NE / (01)00889095069891(10)BAX128NE; BAX250EE / (01)00889095069891(10)BAX250EE; BAX256BE / (01)00889095069891(10)BAX256BE

Product: ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿

Part #: 1124.1215; Lot # / UDI #: BAX112XE / (01)00889095069914(10)BAX112XE; BAX250LE / (01)00889095069914(10)BAX250LE

Product: ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

Part #: 1124.1232; Lot # / UDI #: BAX103UE / (01)00889095069945(10)BAX103UE; BAX138JE / (01)00889095069945(10)BAX138JE; BAX167VE / (01)00889095069945(10)BAX167VE; BAX167UE / (01)00889095069945(10)BAX167UE; BAX227JE / (01)00889095069945(10)BAX227JE; BAX413ME / (01)00889095069945(10)BAX413ME

Product: ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿

Part #: 1124.1233; Lot # /UDI #: BAX196AE / (01)00889095069952(10)BAX196AE; BAX196CE / (01)00889095069952(10)BAX196CE

Product: ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿

Part #: 1124.1235; Lot # / UDI #: BAX103WE / (01)00889095069976(10)BAX103WE; BAX227VE / (01)00889095069976(10)BAX227VE

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86164

Status: Resolved

Manufacturer: Globus Medical, Inc.

Manufactured In: United States

Agency Last Updated: September 2, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.