Ebi Solitaire-C Cervical Spacer Drill Sleeves Recalled for Design Deficiency
Ebi, LLC is recalling 193 units of Solitaire-C Cervical Spacer System drill sleeves because a design defect allows instruments to penetrate 1.0 mm beyond intended depths.
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 involves a medical device with a design deficiency that allows instruments to penetrate beyond intended depths, posing a risk of harm during surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ebi, LLC is recalling 193 units of the Solitaire-C Cervical Spacer System, specifically the Drill/Awl Sleeve (Part Number 14-531593, Lot N23597) and the Spring-Loaded Drill/Awl Sleeve (Part Number 14-531594, Lot N23599). These medical devices are intended to stabilize cervical spinal segments to promote fusion, restrict motion, and decrease pain using bone graft with or without supplemental fixation.
The recall was initiated due to a design deficiency discovered in the Sleeves. This defect allows the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during the preparation of screw holes. The affected products were distributed nationwide in the United States.
Healthcare providers and patients who have used these specific instruments should contact Ebi, LLC for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental…
- Manufacturer
- Ebi, Llc
- Affected units
- 193
Distribution
Distributed nationwide across the United States.
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