Z-0434-06

Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable...

Name: Z-0434-06 Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable...
Creator: Tnco, Inc.
Published: 2005-12-02
License: https://open.fda.gov/license/

Tnco, Inc. / initiated 2005-12-02 / Terminated / root cause: manufacturing process

FDA source

Tnco, Inc. began a recall of Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable Stainless Steel Surgical Instrument Part Number: 125382A on 2005-12-02. The reason FDA records is "The tip may not engage with the handle and may dislodge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0434-06
Status: Terminated
Initiated: 2005-12-02
Posted: 2006-01-24
Terminated: 2006-06-14
Recalling firm: Tnco, Inc.
Product: Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable Stainless Steel Surgical Instrument Part Number: 125382A
Product code: GCK Gastroscope, General & Plastic Surgery
Reason for recall: The tip may not engage with the handle and may dislodge
Root cause tag: manufacturing process
FDA root cause: Process control
Action: TNCO notified customers by telephone and certified letter on 01/2/06. Accounts are requested to return inventory.
Quantity in commerce: 185 units
Distribution: CA, CT, DC, IL, IN, FL. GA, NC, NY, UT Canada
Product codes and lots: Lot Number: 305

Product code GCK

K943958Class IIMonopolar Endoscopic Reposable Tip Surgical InstrumentsTnco, Inc. / cleared 1994-09-07

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)