Amendia recalls

Amendia appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2018-01-17.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Mac Pin Non-Cannulated Screw, 6.5 x 60mm
  FDA Device · Class II · 2018-01-17 · Amendia
  Reason: Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
• Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Cere…
  FDA Device · Class II · 2018-01-10 · Amendia
  Reason: Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14…
• Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of t…
  FDA Device · Class II · 2017-12-20 · Amendia
  Reason: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
• 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755…
  FDA Device · Class II · 2017-05-03 · Amendia
  Reason: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
• Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletall…
  FDA Device · Class II · 2017-01-18 · Amendia
  Reason: Absent tantalum market pin.
• Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed in…
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
• Optimus Fixed Awl
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: Complaints that the tip of the awl broke after impaction during surgery.
• Black Widow Plate 19mm Plate, Part Number TBP119
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
• K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
• Savannah-T Straight Rod, 200mm, Part Number 10704-200
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
• Black Widow 6.6mm x 20mm Screw, Part Number TBS020
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
• Zeus-P Lumbar Interbody Device
  FDA Device · Class II · 2016-12-28 · Amendia
  Reason: 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 pou…