FDAClass IIAugust 11, 2021

Straumann SCS Screwdriver recall

Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

Why was Straumann SCS Screwdriver recalled?

Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury

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?

Packaged lot number: EHG85 Lot Number engraved on part: CXV34

Product
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Recalling firm
Straumann USA LLC
Quantity
130 pieces
Distribution
US Nationwide Distribution
Recall date
August 11, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls