Z-0874-2015Class II

Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve...

Name: Z-0874-2015 Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve...
Creator: Ebi, Llc
Published: 2014-11-11
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2014-11-11 / Terminated / root cause: design

FDA source

Ebi, Llc began a recall of 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... on 2014-11-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0874-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-11
Posted: 2014-12-24
Terminated: 2015-04-15
Recalling firm: Ebi, LLC
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 fixation.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 11/11/2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and remove from circulation the items consigned/loaned to your account as identified; carefully follow the instructions on the enclosed "Response Form"; complete and return Response Form via fax to 303.501.8444, and if you have further distributed these items to medical facilities, you MUST notify them of the actions. Questions related to this notice should be directed to the Sr. Quality Engineer at 518-859-3487 Monday through Friday, 8 am to 4 pm ET.
Quantity in commerce: 193 units
Distribution: US Nationwide Distribution.
Product codes and lots: Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0874-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0874-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24

Product code OVE

K113796Class IISolitaire-C Cervical Spacer SystemEbi, LLC / cleared 2012-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)