FDAClass IIAugust 1, 2018

AD-TECH Medical Instrument Corporation Drill Sleeve recall

AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor…

Why was AD-TECH Medical Instrument Corporation Drill Sleeve recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

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…
Recalling firm
Ad-Tech Medical Instrument Corporation
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.
Recall date
August 1, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls