FDAClass IIApril 3, 2019

Paltop 1.25 Hex Drivers recall

Paltop 1.25 Hex Drivers, Short Part Number: 60-70102

Why was Paltop 1.25 Hex Drivers recalled?

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

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?

Lot Number: WO-010354

Product
Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
Recalling firm
Keystone Dental Inc
Quantity
3 Hex Driver
Distribution
FL, MA, SC, VA
Recall date
April 3, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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