FDA Device recall Z-0286-2019

EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone…

FDA Device
Class I
terminated
Published 2018-11-07

On 2018-11-07 the FDA classified a Class I recall of EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone… by Zimmer Biomet, citing lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0286-2019
Classification	Class I
Status	terminated
Initiated	2018-02-19
Published	2018-11-07
Last updated	2026-09-13 11:54 UTC
Company	Zimmer Biomet
Distribution	US

Product

EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.

Reason

Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

Identifiers

code_info	All serial numbers expiring prior to March 31, 2019 are affected. Item # 10-1320 - OsteoGen 20/S; Serial Numbers: 52… All serial numbers expiring prior to March 31, 2019 are affected. Item # 10-1320 - OsteoGen 20/S; Serial Numbers: 520798, 520841, 521079, 521260, 521446, 521886, 520830, 520795, 520789, 521881, 520705, 520799, 520842, 521080, 521261, 521447, 521887, 520831, 520796, 520793, 521875, 520706, 520800, 520843, 521081, 521262, 521448, 521888, 520832, 520797, 520837, 521439, 520708, 520801, 520844, 521082, 521263, 521449, 521889, 520833, 520839, 520838, 521440, 520709, 520802, 520845, 521083, 521264, 521862, 521890, 520834, 520840, 520884, 521253, 520710, 520803, 520846, 521084, 521265, 521863, 520717, 520875, 520886, 520885, 521254, 520711, 520804, 520867, 521086, 521267, 521864, 520718, 520876, 521078, 521255, 520881, 520712, 520805, 520868, 521087, 521268, 521865, 520719, 520878, 521257, 521256, 520882, 520713, 520806, 520869, 521089, 521269, 521866, 520720, 520879, 521259, 521442, 520835, 520714, 520827, 520871, 521090, 521321, 521867, 520721, 520880, 521444, 521443, 520

code_info

All serial numbers expiring prior to March 31, 2019 are affected. Item # 10-1320 - OsteoGen 20/S; Serial Numbers: 52…

All serial numbers expiring prior to March 31, 2019 are affected. Item # 10-1320 - OsteoGen 20/S; Serial Numbers: 520798, 520841, 521079, 521260, 521446, 521886, 520830, 520795, 520789, 521881, 520705, 520799, 520842, 521080, 521261, 521447, 521887, 520831, 520796, 520793, 521875, 520706, 520800, 520843, 521081, 521262, 521448, 521888, 520832, 520797, 520837, 521439, 520708, 520801, 520844, 521082, 521263, 521449, 521889, 520833, 520839, 520838, 521440, 520709, 520802, 520845, 521083, 521264, 521862, 521890, 520834, 520840, 520884, 521253, 520710, 520803, 520846, 521084, 521265, 521863, 520717, 520875, 520886, 520885, 521254, 520711, 520804, 520867, 521086, 521267, 521864, 520718, 520876, 521078, 521255, 520881, 520712, 520805, 520868, 521087, 521268, 521865, 520719, 520878, 521257, 521256, 520882, 520713, 520806, 520869, 521089, 521269, 521866, 520720, 520879, 521259, 521442, 520835, 520714, 520827, 520871, 521090, 521321, 521867, 520721, 520880, 521444, 521443, 520

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.