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Recall Observatory FDA recall evidence

Device product

djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

Z-2146-2012

July 16, 2012

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 62561
Status
Terminated
Classification
Class II
Quantity
18 devices
Official record key
device-enforcement:Z-2146-2012

Official wording

Reason: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.

Code information: Lot 007A1037, Ref 010-55-25.

Distribution pattern: Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling