Amendia Savannah-T Straight Rods Recalled for Packaging Seal Defects
Amendia, Inc. is recalling Savannah-T Straight Rods because some packages have unacceptable seals with compromised integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves packaging integrity which poses a risk of contamination or device failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Amendia, Inc. is recalling Savannah-T Straight Rods and related spinal fixation devices due to packaging defects. The rods are packaged in packages with unacceptable seals, and in some cases, the integrity of the seal is compromised by channels or voids.
The recall involves 240 units of various Savannah-T Straight Rod models, including 200mm, 250mm, 300mm, 400mm, and 500mm lengths, as well as High Top Straight Rods and Notched Curved Rods. Specific part numbers and lot numbers are listed in the official recall documentation.
These products were distributed nationwide to 26 states and Puerto Rico. Healthcare providers and facilities that have received these products should stop using them and contact Amendia, Inc. for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Amendia, Inc
- Category
- Medical Device — Spinal Fixation
- Affected units
- 240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Amendia, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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