FDA Medical Device Recalls (openFDA)
ASPEN SURGICAL: Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
- Recall number
- Z-2221-2024
- Recalling firm
- ASPEN SURGICAL
- Product
- Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
- Status
- Completed
- Initiated
- 2024-06-03
- Posted
- 2024-06-27
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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 christi.fortenberry@aspensurgical.com. 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 christi.fortenberry@aspensurgical.com 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 christi.fortenberry@aspensurgical.com within 24 hours of receipt. Please contact your Aspen representative if you have any questions or require additional information.
- Quantity
- 1900 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
- 510(k) numbers
- ["K913500"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3002750084
- Firm city
- Caledonia
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28