Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to
FDA device recall Z-0874-2015 · posted 2014-12-24 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- OVE
- Quantity affected
- 193 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2014-11-11
- Date posted
- 2014-12-24
- Date terminated
- 2015-04-15
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLITAIRE-C CERVICAL SPACER SYSTEM (K113796) | Ebi, LLC | 2012-04-26 |