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Recall Observatory FDA recall evidence

Device product

Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.

Z-0406-2014

July 30, 2013

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 66413
Status
Terminated
Classification
Class II
Quantity
13
Official record key
device-enforcement:Z-0406-2014

Official wording

Reason: A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.

Code information: Part No. 249.926, lot No. 8093100

Distribution pattern: Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.