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[Recalled] EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 — Device does not mate as intended | FDA 2015-04-21
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 |
|---|---|
| Brand / manufacturer | DePuy Spine, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1674-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 April 2015 |
| EAN / barcode | 10705034032467 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Device does not mate as intended.
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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