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Recall Observatory FDA recall evidence

Device product

Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011

Z-1557-2013

February 22, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 64830
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-1557-2013

Official wording

Reason: The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.

Code information: Part Number 241.000.011, lot number S2004

Distribution pattern: Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.