Recall Z-1038-2016 ยท GDF Guide, Needle, Surgical
Stryker Instruments Div. of Stryker Corporation
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
| Date | Mar 3, 2016 (initiated Feb 4, 2016) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904172 | ACCUPLACE (TM) Dlp, Inc., Nov 21, 1990 |