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Recall Observatory FDA recall evidence

Device product

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Z-2244-2018

May 04, 2018

Class II

Product summary

Firm
Stryker GmbH
Event
Event 80198
Status
Terminated
Classification
Class II
Quantity
18 parts (10 parts quarantined)
Official record key
device-enforcement:Z-2244-2018

Official wording

Reason: Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm

Code information: Lot # 04857V

Distribution pattern: AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm