🔍 RecallPedia

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures

Class I - Dangerous
🏥 Medical Devices Recalled: March 26, 2014 Acumed Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261. 8, 7 hole SS compression plate: Lot # 300381. 10, 9 hole SS compression plate: Lot # 299641.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Acumed LLC
Reason for Recall:
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures

Product Codes/Lot Numbers:

2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261. 8, 7 hole SS compression plate: Lot # 300381. 10, 9 hole SS compression plate: Lot # 299641.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1515-2014

Related Recalls

Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;

Acumed

Class I - Dangerous

Distribution without Pre-Market Clearance

Dec 19, 2023 Infusion Pumps Nationwide View Details →

Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw 30-0027 40.0mm Acutrak 2¿ - 5.5 Screw 30-0027-S 40.0mm Acutrak 2¿ - 5.5 Screw 30-0029 45.0mm Acutrak 2¿ - 5.5 Screw 30-0029-S 45.0mm Acutrak 2¿ - 5.5 Screw 30-0031 50.0mm Acutrak 2¿ - 5.5 Screw 30-0031-S 50.0mm Acutrak 2¿ - 5.5 Screw 30-0084 55.0mm Acutrak 2¿ - 5.5 Screw 30-0084-S 55.0mm Acutrak 2¿ - 5.5 Screw 30-0085 60.0mm Acutrak 2¿ - 5.5 Screw 30-0085-S 60.0mm Acutrak 2¿ - 5.5 Screw 30-0620 20.0mm Acutrak 2¿ - 4.7 Screw 30-0620-S 20.0mm Acutrak 2¿ - 4.7 Screw 30-0622 22.0mm Acutrak 2¿ - 4.7 Screw 30-0622-S 22.0mm Acutrak 2¿ - 4.7 Screw 30-0624 24.0mm Acutrak 2¿ - 4.7 Screw 30-0624-S 24.0mm Acutrak 2¿ - 4.7 Screw 30-0626 26.0mm Acutrak 2¿ - 4.7 Screw 30-0626-S 26.0mm Acutrak 2¿ - 4.7 Screw 30-0628 28.0mm Acutrak 2¿ - 4.7 Screw 30-0628-S 28.0mm Acutrak 2¿ - 4.7 Screw 30-0630 30.0mm Acutrak 2¿ - 4.7 Screw 30-0630-S 30.0mm Acutrak 2¿ - 4.7 Screw 30-0635 35.0mm Acutrak 2¿ - 4.7 Screw 30-0635-S 35.0mm Acutrak 2¿ - 4.7 Screw 30-0640 40.0mm Acutrak 2¿ - 4.7 Screw 30-0640-S 40.0mm Acutrak 2¿ - 4.7 Screw 30-0645 45.0mm Acutrak 2¿ - 4.7 Screw 30-0645-S 45.0mm Acutrak 2¿ - 4.7 Screw 30-0650 50.0mm Acutrak 2¿ - 4.7 Screw 30-0650-S 50.0mm Acutrak 2¿ - 4.7 Screw 30-0740 40.0mm Acutrak 2¿ - 7.5 Screw 30-0740-S 40.0mm Acutrak 2¿ - 7.5 Screw 30-0745 45.0mm Acutrak 2¿ - 7.5 Screw 30-0745-S 45.0mm Acutrak 2¿ - 7.5 Screw 30-0750 50.0mm Acutrak 2¿ - 7.5 Screw 30-0750-S 50.0mm Acutrak 2¿ - 7.5 Screw 30-0755 55.0mm Acutrak 2¿ - 7.5 Screw 30-0755-S 55.0mm Acutrak 2¿ - 7.5 Screw 30-0760 60.0mm Acutrak 2¿ - 7.5 Screw 30-0760-S 60.0mm Acutrak 2¿ - 7.5 Screw 30-0770 70.0mm Acutrak 2¿ - 7.5 Screw 30-0770-S 70.0mm Acutrak 2¿ - 7.5 Screw 30-0775 75.0mm Acutrak 2¿ - 7.5 Screw 30-0775-S 75.0mm Acutrak 2¿ - 7.5 Screw 30-0780 80.0mm Acutrak 2¿ - 7.5 Screw 30-0780-S 80.0mm Acutrak 2¿ - 7.5 Screw 30-0785 85.0mm Acutrak 2¿ - 7.5 Screw 30-0785-S 85.0mm Acutrak 2¿ - 7.5 Screw 30-0790 90.0mm Acutrak 2¿ - 7.5 Screw 30-0790-S 90.0mm Acutrak 2¿ - 7.5 Screw 30-0795 95.0mm Acutrak 2¿ - 7.5 Screw 30-0795-S 95.0mm Acutrak 2¿ - 7.5 Screw 30-0800 100.0mm Acutrak 2¿ - 7.5 Screw 30-0800-S 100.0mm Acutrak 2¿ - 7.5 Screw 30-0805 105.0mm Acutrak 2¿ - 7.5 Screw 30-0805-S 105.0mm Acutrak 2¿ - 7.5 Screw 30-0810 110.0mm Acutrak 2¿ - 7.5 Screw 30-0810-S 110.0mm Acutrak 2¿ - 7.5 Screw 30-0815 115.0mm Acutrak 2¿ - 7.5 Screw 30-0815-S 115.0mm Acutrak 2¿ - 7.5 Screw 30-0820 120.0mm Acutrak 2¿ - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2¿ Bone Screw

Acumed

Class I - Dangerous

Distribution without Pre-Market Clearance

Nov 29, 2022 Other Medical Devices Nationwide View Details →