OFFICIAL-SOURCE RECALL · AUSTRALIA
Neoss Guide Implant Inserters Recall: Classification Class III Reason for the Action The
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Neoss Guide Implant Inserters
- Manufacturer
- See official notice
- Lot number
- numbers, 200674
- Batch number
- numbers, 200674
- 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 The guide inserters were produced with incorrect laser marking. The physical product is showing ‘S SP’. The correct platform ‘N NP’ is identified on the product label. The incorrect laser marking could potentially cause the user to incorrectly identify the instrument and select an NP inserter for use with an SP implant. Use of the NP inserter with an SP implant is considered highly unlikely to cause any deformation or damage to the implant. Instructions for Customers/Users Customers are to: - Inspect your stock, identify any affected guide inserters of batch number 200674. - If alternative batches are available or the Guide Inserter is not required for any upcoming surgery, quarantine affected stock. - If alternatives are unavailable and the Guide Inserter is required for an upcoming surgery, refer to the product label for the correct platform. Place the inserter in the surgical tray in the designated N NP placeholder. Before use, clean and sterilize the product as described in the applicable Instructions for Use (IFU). Replacement products are expected to be available from the end of September. When replacements are available, please
Hazard
Classification Class III Reason for the Action The guide inserters were produced with incorrect laser marking. The physical product is showing ‘S SP’. The correct platform ‘N NP’ is identified on the product label. The incorrect laser marking could potentially cause the user to incorrectly identify the instrument and select an NP inserter for use with an SP implant. Use of the NP inserter with an SP implant is considered highly unlikely to cause any deformation or damage to the implant. Instructions for Customers/Users Customers are to: - Inspect your stock, identify any affected guide inserters of batch number 200674. - If alternative batches are available or the Guide Inserter is not required for any upcoming surgery, quarantine affected stock. - If alternatives are unavailable and the Guide Inserter is required for an upcoming surgery, refer to the product label for the correct platform. Place the inserter in the surgical tray in the designated N NP placeholder. Before use, clean and sterilize the product as described in the applicable Instructions for Use (IFU). Replacement products are expected to be available from the end of September. When replacements are available, please
Official recall notice
Neoss Guide Implant Inserters
Agency: Therapeutic Goods Administration
Official publication date: July 27, 2026
Read the official AU_TGA_DRAC recall notice →Scan products you own
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