Ebi, Llc: Medical Device Recall in 2014 - (Recall #: Z-0874-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 fixation.

Product Classification:

Class II

Date Initiated: November 11, 2014

Date Posted: December 31, 2014

Recall Number: Z-0874-2015

Event ID: 69981

Reason for Recall:

A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.

Status: Terminated

Product Quantity: 193 units

Code Information:

Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated