Recall Z-0624-2017 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
DePuy Spine, Inc.
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture
| Date | Oct 12, 2016 |
| Status | Terminated |
| Reason | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Root cause | Under Investigation by firm |
| Action | The firm, DePuy Synthes Spine, sent an "URGENT! VOLUNTARY PRODUCT CORRECTION NOTIFICATION" letter dated 10/12/2016 to its Customers. Sales consultants supporting these customers received an email notification with required reply forms. The letter described the product, problem and actions to be taken. A DePuy Synthes Spine Sales consultant has been notified and will be reviewing inventory to ensure correct screw placement within your set. The customers were instructed to review, complete, sign and return the attached business reply form to DePuy Synthes Spine via email to: DPYUS-SpineFieldAct |
| Quantity | 9 units |
| Distribution | US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052552 | HYBRID ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc., Oct 13, 2005 |