Agency classClass IOur severity:Severe FDA (Devices)·Z-0286-2019·Announced 2018-11-07

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Orthopedic Implant
Hazard: contamination
cleanliness

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

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

See all →

High
Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · contamination