FDA Device Intelligence
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Retainer, Surgical

FDA product code GCZ · Class 1 · General, Plastic Surgery

37
Registered devices
39
Adverse events
6
Recalls
5
510(k) clearances

Devices with this code

12mm Distraction Pin — FOLSOM METAL PRODUCTS, INC.Viscera Retainer, Fish — ADEPT MED INTERNATIONAL INCViscera Retainer, Fish — ADEPT MED INTERNATIONAL INC14mm Distraction Pin-Double — FOLSOM METAL PRODUCTS, INC.MATIRA ANTERIOR CERVICAL SYSTEM — Kalitec Direct LLCCross Element Guide Retainer — TOBY ORTHOPAEDICSMATIRA ANTERIOR CERVICAL SYSTEM — Kalitec Direct LLCViscera Retainer, Fish — ADEPT MED INTERNATIONAL INC14mm Distraction Pin-Double — FOLSOM METAL PRODUCTS, INC.Viscera Retainer Radiopaque Center Spine — RAINBOW MEDICAL DEVICES LLCViscera Retainer Radiopaque Center Spine — RAINBOW MEDICAL DEVICES LLC12mm Distraction Pin-Double — FOLSOM METAL PRODUCTS, INC.14mm Distraction Pin — FOLSOM METAL PRODUCTS, INC.Post Drill Guide Sleeve, 28mm — TOBY ORTHOPAEDICSViscera Retainer Radiopaque Center Spine — RAINBOW MEDICAL DEVICES LLCPost Drill Guide Sleeve, 45mm — TOBY ORTHOPAEDICS12mm Distraction Pin-Double — FOLSOM METAL PRODUCTS, INC.Cross Element Guide Sleeve — TOBY ORTHOPAEDICSOmnia Medical TiBrid™- A/SA — OMNIA MEDICAL, LLCViscera Retainer, Fish — ADEPT MED INTERNATIONAL INCSurgeon Sturgeon — FLEXBAR MACHINE CORPORATION14mm Distraction Pin — FOLSOM METAL PRODUCTS, INC.Breast Implant Protector — ADEPT MED INTERNATIONAL INCOmnia Medical TiBrid™- A/SA — OMNIA MEDICAL, LLC

Recent recalls

DateFirmReason
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.