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OFFICIAL-SOURCE RECALL · AUSTRALIA

SACRO Sacrocolpopexy Tips Recall: Classification Class III Reason for the Action

Use the identifiers printed on your item to determine whether this recall may affect the product you own.

CountryAustraliaPublishedJuly 29, 2026Last updatedJuly 29, 2026Official source last checkedAugust 14, 2026 at 7:44 PM UTC

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Is your product affected?

Brand
See official notice
Product
SACRO Sacrocolpopexy Tips
Manufacturer
See official notice
Lot number
numbers, Numbers, 550020368
Batch number
numbers
Date code
dates
Expiration date
dates

The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Classification Class III Reason for the Action Certain LOTs were assembled with an internal hub in the incorrect orientation. The inverted assembly prevents the tip from being attached to the compatible RUMI system or Advincula Arch handle. If the SACRO Sacrocolpopexy Tip cannot be properly attached to the Snap Drum feature on the compatible RUMI System or Advincula Arch Handle, the user may need to select a replacement SACRO Sacrocolpopexy Tip or an appropriate alternative instrument/approach. Instructions for Customers/Users Customers are to: - Inspect their stock and quarantine any

Hazard

Classification Class III Reason for the Action Certain LOTs were assembled with an internal hub in the incorrect orientation. The inverted assembly prevents the tip from being attached to the compatible RUMI system or Advincula Arch handle. If the SACRO Sacrocolpopexy Tip cannot be properly attached to the Snap Drum feature on the compatible RUMI System or Advincula Arch Handle, the user may need to select a replacement SACRO Sacrocolpopexy Tip or an appropriate alternative instrument/approach. Instructions for Customers/Users Customers are to: - Inspect their stock and quarantine any

Official recall notice

SACRO Sacrocolpopexy Tips

Agency: Therapeutic Goods Administration

Official publication date: July 29, 2026

Read the official AU_TGA_DRAC recall notice →

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