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Recall Observatory FDA recall evidence

Device product

Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.

Z-0786-2022

February 15, 2022

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 89507
Status
Terminated
Classification
Class II
Quantity
1 package
Official record key
device-enforcement:Z-0786-2022

Official wording

Reason: An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

Code information: Lot #73967511638696

Distribution pattern: International distribution to the country of France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.