Endoscopic Kittner Blunt Dissecting Instrument, Intended to… recallZ-2221-2024 · Aspen Surgical · initiated Jun 3, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aspen Surgical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
FDA root cause category: Process control
What the company is doing
An URGENT: FIELD SAFETY NOTICE (Removal) dated 6/3/24 was sent to customers. Required Actions: Note: Any further distribution or use of the impacted product should cease immediately. 1. Check all storage and usage locations to confirm if you have any lots of the affected item code in your possession. 2. Distributors Please check your inventory for affected products as indicated above. For products that you have distributed, please forward this notification to your customers who have received affected product. Please also provide to Aspen a list of customers who have received these products, including the number of each product and contact information for each customer, to [email protected]. 3. Review, complete, sign and return the enclosed Acknowledgement Form on Page 3 by following the directions on the form. This will help us verify that you have been successfully supported by this corrective action. 4. Return any affected product found in your inventory. Your sales representative can assist with a Return Material Authorization of affected product if needed. 5. Contact Christi Fortenberry at [email protected] or 615.785.5933 for information on credit or replacement options. 6. Share this notice with others in your facility who need to be aware of this removal. Contact other facilities associated with your organization that may have received units of affected lots. 7. Maintain awareness of this notice until all affected product has been returned to Aspen Surgical. 8. Keep a copy of this notice with affected product until returned to Aspen. Please complete this Acknowledgement of Receipt form and email to [email protected] within 24 hours of receipt. Please contact your Aspen representative if you have any questions or require additional information.
Recall details
- Recall number
- Z-2221-2024
- Status
- Completed
- Initiated by the company
- Jun 3, 2024
- Posted by the FDA
- Jun 27, 2024
- Recalling firm
- Aspen Surgical
- Quantity
- 1900 units
- Product code
- GCJ
- FDA submissions
- K913500
- Distribution
- US Nationwide
Product description
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Code information (models, lots, serial numbers)
UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Aspen® Endoscopic Kittner, Single Tip KT-9101Aspen Surgical Products, Inc. · Laparoscope, general & plastic surgery1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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