Retainer, Surgical
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
39 adverse event reports on file
- VISCERA RETAINER RADIOPAQUE CENER SPINEJan 10, 2025InjuryMW5164580
- VISCERA RETAINER RADIOPAQUE CENTER SPINESep 25, 2024MalfunctionRainbow Medical Devices LlcMW5160108
- ETHILOOP SILICON SLING UNKNOWN PRODUCTOct 11, 2018InjuryEthicon Inc.2210968-2018-76469
- ETHILOOP SILICON SLING UNKNOWN PRODUCTOct 11, 2018InjuryEthicon Inc.2210968-2018-76477
- ANCHOR BOLT - LSB STYLESep 13, 2018MalfunctionAd-tech Medical Instrument Corp.2183456-2018-00006
- ANCHOR BOLT - LSB STYLEAug 29, 2018MalfunctionAd-tech Medical Instrument Corp.2183456-2018-00005
- ANCHOR BOLT - LSB STYLEJun 28, 2018MalfunctionAd-tech Medical Instrument Corp.2183456-2018-00004
- ANCHOR BOLT-LSB STYLEApr 27, 2018MalfunctionAd-tech Medical Instrument Corp.2183456-2018-00002
- ANCHOR BOLT-LSB STYLEApr 27, 2018MalfunctionAd-tech Medical Instrument Corporation2183456-2018-00003
- ANCHOR BOLT-LSB STYLEApr 18, 2018MalfunctionAd-tech Medical Instrument Corp.2183456-2018-00001
Event type breakdown
Recalls
6 recall events for this product code
- Folsom Metal Products, Inc.Open, ClassifiedSep 17, 2025
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Z-2576-2025 · View FDA record ↗ - Folsom Metal Products, Inc.Open, ClassifiedSep 17, 2025
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Z-2577-2025 · View FDA record ↗ - Folsom Metal Products, Inc.Open, ClassifiedSep 17, 2025
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Z-2578-2025 · View FDA record ↗ - Folsom Metal Products, Inc.Open, ClassifiedSep 17, 2025
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Z-2579-2025 · View FDA record ↗ - Folsom Metal Products, Inc.Open, ClassifiedSep 17, 2025
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Z-2580-2025 · View FDA record ↗ - Folsom Metal Products, Inc.Open, ClassifiedSep 17, 2025
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Z-2581-2025 · View FDA record ↗
Registered firms
54 firms currently registered for this product code
Depuy Spine, Inc.
RAYNHAM, MA, US
Premier Guard Zhongshan Limited
Zhongshan Guangdong, CN
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Win Wings Corp.
SIALKOT Punjab, PK
Jmu Dental, Inc
Fullerton, CA, US
Isomedix Operations, Inc.
Temecula, CA, US
The O R Company Pty Ltd
Cheltenham Victoria, AU
S.g. Manufacturers
Sialkot Punjab, PK
Orihealth Medical Products(suzhou)co.,ltd
Suzhou Jiangsu, CN
Hive International Pvt Ltd.
Sialkot Punjab, PK
Metal Craft Machine & Engineering, Inc.
Elk River, MN, US
Tianjin Medicines & Health Products Imp. & Exp. Corp.
Tianjin, CN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Hubei Guarddent Medical Technology Co.,ltd
Wuhan Hubei, CN
Kalitec Direct Llc Dba Kalitec Medical
Sarasota, FL, US
Adept-med Intl., Inc.
DIAMOND SPRINGS, CA, US
Greer Medical, Inc.
Santa Barbara, CA, US
Shandong Zhushi Pharmaceutical Group Co., Ltd
Heze Shandong, CN
Tianjin Water Source Tech Co., Ltd.
Tianjin, CN
Surgicon Pvt Ltd
Sialkot Punjab, PK
Sterigenics U.s., Llc
Corona, CA, US
Sterigenics Us Llc
Charlotte, NC, US
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Lohar Medical Company
Sialkot Punjab, PK
Millennium Surgical Corp
Schaumburg, IL, US
510(k) clearances
5 clearances for this product code
- Jain Surgical Equipment, Inc.Nov 29, 1990
K904536 · JAIN GRAFT ASSIST
- Adept-Med Intl., Inc.Jul 14, 1989
K893870 · ADAMS BREAST IMPLANT PROTECTOR
- Adept-Med Intl., Inc.Mar 19, 1987
K870809 · MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206
- Adept-Med Intl., Inc.Jan 23, 1981
K802806 · VISECERA RETAINER
- Edward Weck, Inc.Aug 4, 1980
K801610 · CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR