K-Wire 1 — Class II medical device recall Z-0881-2017
Terminated recall by Amendia, Inc, reported 2016-12-28, distributed nationwide. The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is comprom
| Recall number | Z-0881-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2024-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 5,833 units |
| Reason classes | packaging |
| Lot numbers | 121306, 121307, 122239, 122468, 122470, 122486, 122487, 122488, 122626, 122628, 122721, 123556, 123564, 123863, 123938, 123948, 123957, 124137, 124400, 124402, 124408, 124547, 125199, 125331, 126125, 126504, 126820, 126821, 127435, 127436, 127437, 127877, 128348, 128351, 128469, 128472, 129005, 129077, 129132, 129443 and 59 more |
| Model numbers | 9080-12U, 9080-18T, 9080-18U, 9080-24T, 9080-24U, 9080-N-18T, 9080-N-18U, 9080B-18T, 9080B-18U, 9080B-24U, 9080B-N-18T, 9080B-N-18U, 9080L-18U |
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 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0881-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.