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