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Recall Observatory FDA recall evidence

Device product

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

Z-2405-2023

June 16, 2023

Class II

Product summary

Firm
Conformis, Inc.
Event
Event 92764
Status
Ongoing
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-2405-2023

Official wording

Reason: 30mm screws were labeled as 25mm screws.

Code information: Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

Distribution pattern: US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    30mm screws were labeled as 25mm screws.