Amendia, Inc: Medical Device Recall in 2016 - (Recall #: Z-0882-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: December 28, 2016

Recall Number: Z-0882-2017

Event ID: 75858

Reason for Recall:

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

Status: Terminated

Product Quantity: 1078 units

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

Voluntary or Mandated:

Voluntary: Firm initiated