Recall Z-0881-2017— Amendia, Inc

Class II FDA medical device recall by Amendia, Inc, initiated 2016-11-22, terminated 2024-02-01. FDA's recall record names no specific 510(k) clearance for this event. 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: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids..

Recalling firm

Amendia, Inc

Classification

Class II

Status

Terminated

Initiated

2016-11-22

Terminated

2024-02-01

Firm location

Marietta, GA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.