Acumed Recalls
15 recalls on record · May 7, 2014 to July 1, 2026 · Medical Devices
Recalls by year
14
17
22
23
24
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 1, 2026Medical DevicesFDA
Acumed LLC recalls Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL
Hazard: Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
March 6, 2024Medical DevicesFDA
Acumed LLC recalls Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Lef
Hazard: Distribution without Pre-Market Clearance
January 3, 2024Medical DevicesFDA
Acumed LLC recalls RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an
Hazard: Due to potential breakage during use.
January 4, 2023Medical DevicesFDA
Acumed LLC recalls Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm
Hazard: Distribution without Pre-Market Clearance
January 4, 2023Medical DevicesFDA
Acumed LLC recalls AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw
Hazard: Distribution without Pre-Market Clearance
January 4, 2023Medical DevicesFDA
Acumed LLC recalls 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
Hazard: Distribution without Pre-Market Clearance
January 4, 2023Medical DevicesFDA
Acumed LLC recalls Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bo
Hazard: Distribution without Pre-Market Clearance
April 27, 2022Medical DevicesFDA
Acumed LLC recalls 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Hazard: Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
April 27, 2022Medical DevicesFDA
Acumed LLC recalls 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Hazard: Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
June 7, 2017Medical DevicesFDA
Acumed LLC recalls The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device i
Hazard: The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
March 22, 2017Medical DevicesFDA
Acumed LLC recalls .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diame
Hazard: Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).
February 22, 2017Medical DevicesFDA
Acumed LLC recalls 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varyi
Hazard: The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.
January 18, 2017Medical DevicesFDA
Acumed LLC recalls OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium
Hazard: OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.
May 7, 2014Medical DevicesFDA
Acumed LLC recalls The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 9
Hazard: Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
May 7, 2014Medical DevicesFDA
Acumed LLC recalls The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/S
Hazard: Manufacturing of these devices with a grade of stainless steel that is not within specifications.