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Class 2 Device Recall SavannahT Rods |
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Date Initiated by Firm |
November 22, 2016 |
Create Date |
December 22, 2016 |
Recall Status1 |
Terminated 3 on February 01, 2024 |
Recall Number |
Z-0883-2017 |
Recall Event ID |
75858 |
510(K)Number |
K161842 K152920 K153152 K132925
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Product Classification |
Orthosis, spondylolisthesis spinal fixation - Product Code MNH
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Product |
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, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone |
Code Information |
Part Number 10704-200 Lot Number 124422, 129766, 130739, 132430; Part Number 10704-250 Lot Number 129790, 130738, 131211, 131309, 131310, 131509, 132811; Part Number 10704-300 Lot Number 129862, 134229; Part Number 10704-400 Lot Number 129861, 130145, 130147, 130502, 131499, 131646; Part Number 10704-500 Lot Number 127934, 127937, 129770, 129863, 130130, 130143, 130781, 134228; Part Number 10705-200 Lot Number 122654, 123583, 129773, 130131, 132153, 132154, 132762; Part Number 10705-220 Lot Number 128818, 131311, 132881; Part Number 10705-240 Lot Number 130500; Part Number 10705-260 Lot Number 121521, 131500, 132199; Part Number 10705-280 Lot Number 121519, 130740; Part Number 10705-300 Lot Number 130140, 130332, 134299; Part Number 10706-200 Lot Number 128522, 129567, 129781, 129891, 130741; Part Number 10707-200 Lot Number 128815, 129782, 129783, 129784, 130182, 131410, 132880. |
Recalling Firm/ Manufacturer |
Amendia, Inc 1755 W Oak Pkwy Marietta GA 30062-2260
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For Additional Information Contact |
Bryan Brosseau 404-610-7215
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Manufacturer 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.
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FDA Determined Cause 2 |
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 in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = MNH and Original Applicant = AMENDIA, INC.
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