Reported Dec 28, 2016 · Terminated
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…
Amendia, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amendia, Inc · 1755 W Oak Pkwy · Marietta, GA · 30062-2260
Is this the product you have?
13 of 13 products
| Model / number | Product as published |
|---|---|
9080-12U | K-Wire 1.4mm x 12in Non-Threaded |
9080-18T | K-Wire Threaded 1.4mm x 18 |
9080-18U | K-Wire Non-Threaded 1.4mm x 18 |
9080-24T | 4mm x 24 Threaded Guide Wire |
9080-24U | K-Wire Non-Threaded 24 |
9080B-18T | Blunt K-Wire, 18 inches, Threaded |
9080B-18U | Blunt K-Wire, 18 inches, Unthreaded |
9080B-24U | Blunt K-Wire, 24 inches, Unthreaded |
9080B-N-18T | 4mm x 18 Blunt Threaded Nitinol Guide Wire |
9080B-N-18U | 4mm x 18" Blunt Non-Threaded Nitinol Guide Wire |
9080L-18U | Lodestar K-wire Non-Threaded, 18 |
9080-N-18T | 4mm x 18 Threaded Nitinol Guide Wire |
9080-N-18U | 4mm x 18 Non-Threaded Nitinol Guide Wire, The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone |
- Amount recalled
- 5833 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Amendia, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.