Amendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery
Amendia is recalling 15 units of K-Wires labeled as stainless steel but made of nitinol. The wires were distributed to Georgia, Kansas, and Texas.
What this means for you
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 source text describes a material mislabeling issue without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving labeling errors or low-risk contamination where harm has not been reported.
Plain-English summary
Amendia, Inc. is recalling 15 units of 01.4mm x 457mm (18in) K-Wires, Threaded Blunt, Reference 9080B-18T, Lot Number 135561. These guide wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery.
The recall was initiated because it was discovered that some of the guide wires were labeled as stainless steel but were actually manufactured from nitinol. This mislabeling represents a discrepancy between the stated material composition and the actual material used in the device.
The affected units were distributed in the United States to Georgia, Kansas, and Texas. The source text does not specify if any injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal s
- Manufacturer
- Amendia, Inc
- Affected units
- 15
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 (1)
- Lot Number 135561
Distribution
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