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 Class 2 Device Recall PalTopsee related information
Date Initiated by FirmFebruary 22, 2019
Create DateMarch 27, 2019
Recall Status1 Terminated 3 on June 19, 2020
Recall NumberZ-1064-2019
Recall Event ID 82374
510(K)NumberK112795 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductPaltop 1.25 Hex Drivers, Short Part Number: 60-70102
Code Information Lot Number: WO-010354
Recalling Firm/
Manufacturer		 Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information ContactSAME
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 2		Process control
ActionKeystone 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 Commerce3 Hex Driver
DistributionFL, MA, SC, VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DZE
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