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Recall Observatory FDA recall evidence

Device product

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

Z-2198-2021

May 27, 2021

Class II

Product summary

Firm
Straumann USA LLC
Event
Event 88282
Status
Terminated
Classification
Class II
Quantity
130 pieces
Official record key
device-enforcement:Z-2198-2021

Official wording

Reason: 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

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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