Recall Z-1547-2015— Alphatec Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2015-04-10, terminated 2015-07-10. It names one FDA 510(k) clearance: K102820. Product: 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. 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..
- Recalling firm
- Alphatec Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-10
- Terminated
- 2015-07-10
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.