Z-0882-2017 Class II Terminated
FDA device recall Z-0882-2017 was initiated by Amendia, Inc on November 22, 2016 and is designated Class II. 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. The recall status is terminated (terminated February 1, 2024). Affected quantity: 1078 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 22, 2016
- Termination Date
- February 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1078 units
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
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.
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
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