Z-2221-2024Class II

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model...

Name: Z-2221-2024 Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model...
Creator: Aspen Surgical
Published: 2024-06-03
License: https://open.fda.gov/license/

Aspen Surgical Products, Inc. / initiated 2024-06-03 / Completed / root cause: manufacturing process

FDA source

ASPEN SURGICAL began a recall of Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101 on 2024-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2221-2024
Classification: Class II
Status: Completed
Initiated: 2024-06-03
Posted: 2024-06-27
Recalling firm: Aspen Surgical Products, Inc.
Product: Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: 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 tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 1900 units
Distribution: US Nationwide
Product codes and lots: UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2221-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2221-2024	Class II	Completed	Voluntary: Firm initiated	2024-07-03	2024-06-27

Product code GCJ

K913500Class IICherry SpongeO.R. Concepts, Inc. / cleared 1991-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)