FDANovember 22, 2016device
Zeus-P Lumbar Interbody Device
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
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
- FDAMac Pin Non-Cannulated Screw, 6.5 x 60mm2017-07-07
- 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
- 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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