Amendia Recalls K-Wires Due to Unacceptable Packaging Seals
Amendia, Inc. is recalling 5,833 units of K-Wires because the packaging seals are unacceptable, with some showing compromised integrity due to channels or voids.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the issue is limited to packaging defects (unacceptable seals) with no reported injuries, illnesses, or functional device failures mentioned in the source text.
Plain-English summary
Amendia, Inc. is recalling 5,833 units of various K-Wire models, including threaded, non-threaded, and blunt guide wires. The affected products are identified by specific part numbers and lot numbers listed in the recall documentation.
The recall is being conducted because the rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. The products were distributed nationwide to specific states and Puerto Rico.
Consumers and healthcare facilities should stop using the affected K-Wires and contact Amendia, Inc. for instructions on how to return or dispose of the products.
The recalled product
- Product
- K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18…
- Manufacturer
- Amendia, Inc
- Hazard
- Affected units
- 5,833
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 9080-12U Lot Number 121306
- 121307
- 122628
- 122721
- 124400
- 132732
- 135403
- Part Number 9080-18T Lot Number 122486
- 122626
- 123957
- 124408
- 127435
- 129132
- 129803
- 129935
- 131072
- 135560
- 135566
- 135567
- Part Number 9080-18U Lot Number 122470
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.
See all 3 products in this recall →Related recalls
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