Recall Z-0883-2017 · MNH Orthosis, Spondylolisthesis Spinal Fixation
Amendia, Inc
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Prod
| Date | Nov 22, 2016 |
| Status | Terminated |
| Reason | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. |
| Root cause | Employee error |
| Action | Amendia sent an Urgent Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that customers examine their inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. Customers with questions were instructed to call the following numbers: 770-575-5224 770-575-5236 770-575-5369 For questions regarding this recall call 404-610-7215. |
| Quantity | 240 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132925 | SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK Amendia, Inc., Feb 11, 2014 |
| K152920 | Savannah-T® Pedicle Screw System Amendia, Inc., Jul 8, 2016 |
| K153152 | Syzygy Stabilization System Amendia, Inc., Apr 27, 2016 |
| K161842 | Overwatch Spine System Amendia, Inc., Oct 13, 2016 |