SpineFrontier, Inc. Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Brand
SpineFrontier, Inc.
Lot Codes / Batch Numbers
Lot number: 20856
Products Sold
Lot number: 20856
SpineFrontier, Inc. is recalling Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after due to During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026