FDA Enforcement
Class II
Terminated
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.
Recall: Z-0874-2015
·
Reported December 31, 2014
Enforcement
- Recall Number
- Z-0874-2015
- Event ID
- 69981
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ebi, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 31, 2014
- Initiation Date
- November 11, 2014
- Classification Date
- December 24, 2014
- Termination Date
- April 15, 2015
- Address
- 399 Jefferson Rd, Parsippany, NJ, 07054-3707, United States
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.
Reason
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.
Code Info
Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599
Distribution
US Nationwide Distribution.
Quantity
193 units