Z-1038-2016Class II

(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined...

Name: Z-1038-2016 (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-02-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-02-04 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography on 2016-02-04. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1038-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-04
Posted: 2016-03-03
Terminated: 2017-05-09
Recalling firm: Stryker Corp.
Product: (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Product code: GDF Guide, Needle, Surgical
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Stryker sent URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to Customers via Overnight service. Stryker Sales Representatives were notified via email. 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many AccuPlace" Needle Guides are at your facility. Discontinue use of the AccuPlace" Needle Guides. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to [email protected]. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. In addition, Stryker Instruments sent recall notifications directly to facilities that received recalled product(s) originally shipped by Inrad. Facilities that received products from both Stryker and Inrad will receive one recall notification. The Business Reply Form will be pre-filled to indicate specifically what recalled products were sent to each facility, including the quantity and Product Number(s).
Quantity in commerce: 5,800 units total
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1038-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1037-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03
Z-1038-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03
Z-1039-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03
Z-1040-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03

Product code GDF

K904172Class IAccuplace (Tm)Dlp, Inc. / cleared 1990-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)