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Recall Observatory FDA recall evidence

Device product

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Z-0380-2014

July 31, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66411
Status
Terminated
Classification
Class II
Quantity
98
Official record key
device-enforcement:Z-0380-2014

Official wording

Reason: Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

Code information: Lot 3420620

Distribution pattern: Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling