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Recall Observatory FDA recall evidence

Device product

Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

Z-1113-2017

December 22, 2016

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 76156
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1113-2017

Official wording

Reason: The product is being recalled due to incidence and reports of the product breaking during surgery.

Code information: Device Listing: D267957

Distribution pattern: Distributed throughout the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product is being recalled due to incidence and reports of the product breaking during surgery.