(Stryker) AccuPlace Straight Level Needle Guide; Assists the user… — Class II medical device recall Z-1037-2016
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-03-09, distributed nationwide. During an evaluation of the product packaging, it was determined that there is a potential for the product to
| Recall number | Z-1037-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2016-02-04 |
| Classified | 2016-03-03 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 5,800 units |
| Reason classes | sterility |
| Lot numbers | 61405002, 61406007, 61408002, 61509002 |
| Model numbers | 0900-300-000 |
Product
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Reason for recall
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.
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-1037-2016. 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.