Acumed Recalls — US Product Safety History

Acumed LLC recalls The Acumed Slide-Loc Anatomic Radial Head System is intended

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.

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Acumed LLC recalls .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pa

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).

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Acumed LLC recalls 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone

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.

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Acumed LLC recalls OPT Croutons is a synthetic bone substitute designed for the

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.

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Acumed LLC recalls Acu-Loc and Acu-Loc 2 bone plates, screws and accessories fo