SpineFrontier Recalls Straight Impactor Devices Due to Handle Plate Breakage
SpineFrontier, Inc. is recalling 10 Straight Impactor - Dorado IBC devices because the impactor plate on the handle broke off during use.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (broken plate) during a surgical procedure. While no injuries are explicitly reported in the source text, the risk of harm from a device component breaking during use places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
SpineFrontier, Inc. is recalling 10 units of the Straight Impactor - Dorado IBC (Part Number: SI02140, Lot Number: 20856). This medical device is used to position implants after they have been inserted into the disc space during the implantation of intervertebral body fusion devices.
The recall was initiated because, on two separate occasions, an impactor plate on the handle broke off while the device was being struck by a mallet. The affected units were distributed worldwide, including nationwide in the United States to the states of Colorado, Massachusetts, and Texas, as well as to Jamaica.
Healthcare providers and consumers should stop using the affected devices immediately. SpineFrontier, Inc. is the recalling firm responsible for managing this Class II recall.
The recalled product
- 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.
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 10
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 (1)
- Lot number: 20856
Distribution
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