Zimmer Biomet Recalls OsteoGen Bone Growth Stimulators for Cleanliness Issues
Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source metadata explicitly identifies this as an FDA Class I recall. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,879 units of the EBI Osteogen Implantable Bone Growth Stimulator. The recall is due to a lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. The affected devices are indicated for the treatment of long bone nonunions.
The recall covers units distributed nationwide in the United States and in Australia. According to the source data, 2,982 units have been implanted and 537 have been scrapped. The affected serial numbers are those expiring prior to March 31, 2019, across various item numbers including 10-1320, 10-1328S, 10-1320M, 10-1328M, 10-1318, 10-1348S, 10-1322S, 10-1348M, and 10-1322M.
This is an FDA Class I recall, which is the most serious type of recall. Patients who have had these devices implanted should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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