Medical DeviceView official recall notice →
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Brand / Firm
Product
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Reason for recall
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Units affected
633 units
Description
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.