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

Class I - Dangerous

🏥 Medical Devices Recalled: November 22, 2016 Amendia Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Amendia, Inc
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0883-2017

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