Amendia, Inc

Complete recall history across all FDA and CPSC categories — 11 total recalls

Amendia, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (11)

FDA medical device enforcement actions by Amendia, Inc

Date Product Reason Class
Jul 7, 2017 Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-dr... Incorrect direct marking and color identification for the affected lot of Cer... Class II
Jul 7, 2017 Mac Pin Non-Cannulated Screw, 6.5 x 60mm Incorrect labeling for the lot of MAC Pins. Although the pins are laser as ... Class II
Apr 6, 2017 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... Mislabeled guide wires - It was discovered that some Guide Wires labeled as s... Class II
Nov 22, 2016 Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plat... There is a problem with the mating feature between the plate and screw which ... Class II
Nov 22, 2016 Ceres-C Standalone Cervical Interbody The product is a stand-alone anterio... Absent tantalum market pin. Class II
Nov 22, 2016 Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Ro... The rods are packaged in packages with unacceptable seals. In some cases, th... Class II
Nov 22, 2016 Optimus Fixed Awl Complaints that the tip of the awl broke after impaction during surgery. Class II
Nov 22, 2016 Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through ... The rods are packaged in packages with unacceptable seals. In some cases, th... Class II
Nov 22, 2016 Zeus-P Lumbar Interbody Device Labeling error where three boxes in inventory had conflicting patient and pri... Class II
Nov 22, 2016 Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm ... There is a problem with the mating feature between the plate and screw which ... Class II
Nov 22, 2016 K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm... The rods are packaged in packages with unacceptable seals. In some cases, th... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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