Food, drugs, devices › Stryker Instruments Div. of Stryker Corporation
Device recall: (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for c
FDA enforcement event 73172 is a device recall by Stryker Instruments Div. of Stryker Corporation of Portage, MI, initiated 4 Feb 2016 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 9 May 2017. Initiation: voluntary: firm initiated. Stryker Instruments Div. of Stryker Corporation has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stryker Instruments Div. of Stryker Corporation, Portage, MI.
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."
Distribution
"Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1037-2016 | (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. | 5,800 units total | Class II | Terminated | 9 Mar 2016 |
| Z-1038-2016 | (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. | 5,800 units total | Class II | Terminated | 9 Mar 2016 |
| Z-1039-2016 | 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. | 5,800 units total | Class II | Terminated | 9 Mar 2016 |
| Z-1040-2016 | 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. | 5,800 units total | Class II | Terminated | 9 Mar 2016 |
Context
Other enforcement events for Stryker Instruments Div. of Stryker Corporation
All 55 events for Stryker Instruments Div. of Stryker Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 May 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.