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.
FDA Recall Z-0874-2015 · Posted 2014-12-24
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Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeOVE
Date Initiated2014-11-11
Date Terminated2015-04-15
Product Quantity193 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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