FDA Device recall Z-1039-2016
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide by Stryker Instruments Div, citing during an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1039-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-04 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Reason
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Identifiers
| code_info | 50000 Lot numbers: 61305001, 61310001, 61312001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labe…50000 Lot numbers: 61305001, 61310001, 61312001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1039-2016%22
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