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Recall Observatory FDA recall evidence

Device product

Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.

Z-2483-2015

July 28, 2015

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 71850
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2483-2015

Official wording

Reason: The device was assembled without screw hole plugs.

Code information: Part Number:135250; Lot Number:946410

Distribution pattern: Distributed in Canada and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device was assembled without screw hole plugs.