FDANovember 22, 2016device
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, Pa...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
What to do
FDA enforcement status: Terminated
Brands named
amendia
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPiranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is inten...2017-11-13
- FDACeres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.2017-07-07
- FDAMac Pin Non-Cannulated Screw, 6.5 x 60mm2017-07-07
- FDA01.4mm 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 surgery2017-04-06
- FDABlack Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar t...2016-11-22
- FDAOptimus Fixed Awl2016-11-22
- FDACeres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.2016-11-22
- FDADual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone2016-11-22
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