Z-1038-2016 Class II Terminated
FDA device recall Z-1038-2016 was initiated by Stryker Instruments Div. Of Stryker Corporation on Feb 4, 2016 and is designated Class II. 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. The recall status is terminated (terminated May 9, 2017). Affected quantity: 5,800 units total.
Recall details
- Product Type
- Devices
- Report Date
- Mar 9, 2016
- Initiation Date
- Feb 4, 2016
- Termination Date
- May 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,800 units total
Product description
(Stryker) AccuPlace Round 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.
Distribution pattern
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.
Code information
Stryker Model: 0900-400-000; With lot numbers: 61406002, 61505003. 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1038-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026