4 — Class II medical device recall Z-1547-2015
Terminated recall by Alphatec Spine, Inc., reported 2015-05-06, distributed in AL, AR, AZ, CA, CO, FL, IN, KS…. During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marke
| Recall number | Z-1547-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2015-04-10 |
| Classified | 2015-04-29 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-07-10 |
| Distributed | AL, AR, AZ, CA, CO, FL, IN, KS, KY, LA, NH, NJ, OK, OR, TN, UT, WI |
| Countries outside the US | BE, ES, JP, SA |
| Reason classes | labeling |
| Lot numbers | 685904 |
| Model numbers | 71240-14 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1547-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.