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Recall Observatory FDA recall evidence

Device product

Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.

Z-1062-2013

January 11, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 64200
Status
Terminated
Classification
Class II
Quantity
328
Official record key
device-enforcement:Z-1062-2013

Official wording

Reason: Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.

Code information: Part number 355.28, all lot numbers

Distribution pattern: Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.