DePuy Spine VIPER POLY SCREW 5 — Class II medical device recall Z-0712-2013
Terminated recall by DePuy Spine, Inc., reported 2013-01-30, distributed nationwide. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long scr
| Recall number | Z-0712-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2012-11-07 |
| Classified | 2013-01-23 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 6 units |
Product
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Reason for recall
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
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-0712-2013. 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.