[Recalled] DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc di
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 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 degeneratio |
|---|---|
| Brand / manufacturer | DePuy Spine, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0627-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 October 2016 |
| EAN / barcode | 186852026 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from DePuy Spine, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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