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Recall Observatory FDA recall evidence

Device product

Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

Z-0882-2017

November 22, 2016

Class II

Product summary

Firm
Amendia, Inc
Event
Event 75858
Status
Terminated
Classification
Class II
Quantity
1078 units
Official record key
device-enforcement:Z-0882-2017

Official wording

Reason: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

Code information: Part Number 812-11R-15 Lot Number 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, 137302

Distribution pattern: Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.