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Recall Observatory FDA recall evidence

Device product

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Z-0323-2016

November 02, 2015

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 72553
Status
Terminated
Classification
Class II
Quantity
229
Official record key
device-enforcement:Z-0323-2016

Official wording

Reason: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

Code information: Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm

Distribution pattern: Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect package