Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile
FDA device recall Z-1694-2009 · posted 2009-08-19 · Terminated
Recall details
- Recalling firm
- X Spine Systems Inc
- Reason for recall
- A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).
- Action taken
- X Spine Systems Inc. issued advisory notices in March 2009 to Consignees notifying them of the problem and requesting all affected product be returned to the firm. The firm also conducted telephone calls and emails for the return of the product. For further information, contact X Spine Systems Inc. at 1-937-847-8400 extension 115.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 9,613 units
- Distribution
- Worldwide Distribution -- Including states of AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT and WY and countries of Spain, South Africa and the United Kingdom.
- Date initiated
- 2009-03-24
- Date posted
- 2009-08-19
- Date terminated
- 2012-04-25
- Location
- Miamisburg, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPLESS LI PEDICLE SCREW SYSTEM (K072282) | X-Spine Systems, Inc. | 2007-09-14 |