Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
FDA Recall Z-1063-2019 · Posted None
Advertisement
Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2019-02-22
Date Terminated2020-06-19
Product Quantity3 hex Driver
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
Firm 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.
Root Cause
Process control
Distribution Pattern
FL, MA, SC, VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement