Recall Z-2539-2018
Ad-Tech Medical Instrument Corporation · initiated May 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.
Codes / lots: Catalog Number DSG-6.3-090-2.4N. Batch Number (Lot Number): 107104 (710220), 114390 (715001), 111423 (716180), 105176 (613121), 113775 (719190), 115847 (712211), 113776 (719190), 115000 (714201), 114724 (711101), 116389 (712121), 117146 (810110).
Reason for recall
The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
FDA-determined cause: Nonconforming Material/Component
Action taken
Customers were notified on 05/02/2018 via a MEDICAL DEVICE RECALL letter. Instructions included to immediately examine your inventory and quarantine any product subject to recall and replacement. Customers/distributors who received affected devices will be contacted to return their unopened/unused and/or reused stock of the affected product.
Details
- Recall number
- Z-2539-2018
- Initiated
- May 2, 2018
- Terminated
- February 8, 2019
- Product code
- HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Quantity
- 65 Total
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MI, NH, NY, OH, OR, PA, SC, UT, WV. Worldwide distribution to Canada, Denmark, Germany, India, Israel, Japan, Russia, South Korea, Taiwan, United Kingdom.
- Recalling firm
- Ad-Tech Medical Instrument Corporation, Oak Creek, WI