Spine Frontier Inspan Compressors Recalled for Potential Weld Breakage
SpineFrontier, Inc. is recalling 17 Inspan compressors because they may break at the weld, causing a loss of compression 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 (weld breakage) that could lead to loss of compression in a medical device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
SpineFrontier, Inc. is recalling 17 units of Inspan compressors, Part Number 11-60004. These medical devices are used to provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
The recall was initiated because the compressors may break at the weld, which could cause a loss of compression. The affected units are identified by Lot Numbers SFP02323, SFP02323R, and SFP02323RR.
The products were distributed worldwide, including nationwide in the United States (including Puerto Rico and the states of FL, MA, MO, OK, and TX) and in Mexico. Users should stop using the affected compressors and contact SpineFrontier, Inc. for further instructions.
The recalled product
- Product
- Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 17
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 (3)
- Lot Numbers: SFP02323
- SFP02323R
- and SFP02323RR
Distribution
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