Recall Z-1547-2015 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Alphatec Spine, Inc.
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
| Date | Apr 29, 2015 (initiated Apr 10, 2015) |
| Status | Terminated |
| Reason | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling. |
| Root cause | Employee error |
| Action | Alphatec Spine sent an Urgent-Medical Device Recall Notification dated April 7, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm first requested that customers notify their consignees of the recall and the risk, and risk mitigation factors. The firm requests that customers take the following field actions: -Upon receipt of the Field Safety Notice to review inventory to determine if affected screw --part number 71240-14, lot 685904 is in their possession. -If the product is in their possession to please |
| Quantity | (244 units in US and 61 units OUS) |
| Distribution | Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102820 | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Alphatec Spine, Inc., Nov 5, 2010 |