PlainRecalls

Amendia, Inc

Compiled from official public sources by the editorial team.

11 recalls on record · Latest: Jan 17, 2018

Amendia, Inc Recall Insight

Amendia, Inc appears on 11 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.011% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jan 17, 2018, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 11 entries, severity tagging shows 0 critical, 11 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 11 of 11 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (11). The date window on this page runs from Dec 28, 2016 to Jan 17, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jan 17, 2018

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

FDA Devices Moderate Jan 10, 2018

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 Ceres-C Sta…

FDA Devices Moderate May 3, 2017

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 West Oak …

FDA Devices Moderate Jan 18, 2017

Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally matur…

FDA Devices Moderate Dec 28, 2016

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…

FDA Devices Moderate Dec 28, 2016

Black 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 T…

FDA Devices Moderate Dec 28, 2016

Zeus-P Lumbar Interbody Device

FDA Devices Moderate Dec 28, 2016

Dual 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 bo…

FDA Devices Moderate Dec 28, 2016

Optimus Fixed Awl

FDA Devices Moderate Dec 28, 2016

Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Num…

FDA Devices Moderate Dec 28, 2016

Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are d…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.