U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: February 22, 2019
Create Date: March 27, 2019
Recall Status: Open, Classified
Recall Number: Z-1061-2019
Recall Event ID: 82374
510(K)Number: K112795
Product Classification: Implant, endosseous, root-form - Product Code DZE
Product: Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver
For surgical and restorative applications prosthetic devices, such as artificial teeth
Part Number: 60-70112
Code Information: Lot Numbers: WO-010252, WO-010136
Recalling Firm/Manufacturer: Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact: SAME
866-902-9272
Manufacturer Reason
for Recall Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
FDA Determined Cause: Process control
Action: Keystone Dental initiated recall by phone to each one of the impacted customers. The phone call was then followed by a Recall Notification Letter that was mailed via overnight FedEx mail on February 22, 2019. Letters states problem and action to take: Replacement 1.25mm Hex Driver(s) have been provided to you with this letter. The 1.25mm Hex Driver(s) currently in your kit should be discarded. Please refer to the images on page 2 to locate the driver within your kit. This issue is limited to this 1.25mm Hex Driver(s) only and no other product within the kit is affected by this issue. Complete the Reply Communication form.
Quantity in Commerce: 13 kits hex Driver
Distribution: FL, MA, SC, VA
Total Product Life Cycle: TPLC Device Report
Original source can be found here.
