Retractor Components

Recalling firm: Integra Neurosciences Pty Ltd (NZ)
Product: Retractor Components. [Device]. Model: Integra Omni-Tract Surgical Retractor System; Integra Omni-Tract Surgical Retractor System; Integra Omni-Tract Surgical Retractor System. Affected: All lot numbers; All lot numbers; All lot numbers. Also covers: Omni-Tract Radiolucent; Omni-Tract Obesity Blades
Reason: An Instructions for Use (IFU) update has been issued for the Omni-Tract Surgical Retractor System to update validated steam sterilisation parameters and approved configurations. The previous IFU specified a 30-minute drying time; however, validation has confirmed that longer drying times (90–120 minutes depending on cycle exposure) are required to ensure adequate drying in pre-vacuum steam sterilisation cycles., The correction also removes rigid container use and gravity displacement sterilisation as approved methods, as these configurations have not been validated., This update is to...
Classification: Class I
Category: medical device recall
Country: New Zealand
Agency: MEDSAFE
Recall date: 2026-06-29
Status: Ongoing
Distribution: New Zealand - Hospital/Pharmacy/Laboratory

Recall details on Nibble Recalls: https://trynibble.app/recalls/fb410987-4881-4ca9-9f37-ca1d697f0b30