Z-0874-2015 Class II Terminated
FDA device recall Z-0874-2015 was initiated by Ebi, Llc on November 11, 2014 and is designated Class II. 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 th… The recall status is terminated (terminated April 15, 2015). Affected quantity: 193 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 11, 2014
- Termination Date
- April 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 193 units
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.
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599